Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

NCT04816643 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: C45910072020-005442-42
• Study Type: interventional
• Target: 11,837
• Locations: 6 countries
• Sites: 128

Brief Summary

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.

Conditions

SARS-CoV-2 Infection, COVID-19

Keywords

COVID-19; Coronavirus Vaccine; SARS-CoV-2; RNA Vaccine; mRNA Vaccine

Outcome Measures

Primary Outcomes (90)

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age

  Local reactions were collected in electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after Dose 1. Redness and swelling were measured and recorded in measuring device unit (mdu) where, 1 mdu = 0.5 centimeter (cm) and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 Emergency room (ER) visit or hospitalization). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% confidence interval was based on Clopper and Pearson method.

  Phase 1: From Day 1 to Day 7 after Dose 1

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 2

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 3

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 degree Celsius (deg C); categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 1

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 2

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 3

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 1

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 2

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 3

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 1

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 2

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 3

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 1

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 2

• Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization for severe tenderness at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 3

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of Age

  Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 1. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted). Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 1

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of Age

  Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 2.Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake),severe (refusal to feed).Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted).Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 2

• Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of Age

  Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 3. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity).Irritability: mild (easily consolable), moderate (requiring increased attention), severe(Inconsolable; crying cannot be comforted).Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

  Phase 1: Day 1 to Day 7 after Dose 3

• Phase 1: Percentage of Participants Reporting Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 1: From Dose 1 to 1 Month after Dose 2

• Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 3 to 1 Month after Dose 3

• Phase 1: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 2: >=5 to <12 Years of Age

  A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 1 to 6 Months after Dose 2

• Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 3 to 6 Months after Dose 3

• Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 1: From Dose 1 to 1 Month after Dose 2

• Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=2 to <5 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 1: From Dose 3 to 1 Month after Dose 3

• Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 1 to 6 Months after Dose 2

• Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=2 to <5 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 3 to 6 Months after Dose 3

• Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=6 Months to <2 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 1: From Dose 1 to 1 Month after Dose 2

• Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=6 Months to <2 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method.Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 1: From Dose 3 to 1 Month after Dose 3

• Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=6 Months to <2 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic.Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 1 to 6 Months after Dose 2

• Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.

  Phase 1: From Dose 3 to 6 Months after Dose 3

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild \>2.0 to 5.0 cm), moderate (\>5.0 to 10.0), severe \>10.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild \>2.0 to 5.0 cm), moderate (\>5.0 to 10.0), severe \>10.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild \>2.0 to 5.0 cm),moderate (\>5.0 to 10.0), severe \>10.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild \>2.0 to 5.0 cm), moderate (\>5.0 to 10.0), severe \>10.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=5 to <12 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 1 to 1 Month after Dose 2

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=12 to <16 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 1 to 1 Month after Dose 2

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group: >=5 to <12 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 3 to 1 Month after Dose 3

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group:>=12 to <16 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month from dose 3 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 3 to 1 Month after Dose 3

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : Troponin Group: >=5 to <12 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 1 to 6 Months after Dose 2

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Troponin Group: >=12 to <16 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 1 to 6 Months after Dose 2

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: Troponin Group: >=5 to <12 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 3 to 6 Months after Dose 3

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : Troponin Group:>=12 to <16 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 3 to 6 Months after Dose 3

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(\>=0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm),severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity),moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments up to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe(prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments up to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 deg C; categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=5 to <12 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments up to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 deg C; categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis\[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity),severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 deg C; categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of Age

  Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 C; categorized as \>=38.0 deg C, 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: \>2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where,1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 (ER visit or hospitalization).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where,1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate(hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 (ER visit or hospitalization).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of Age

  Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where,1 mdu =0.5 cm and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 (ER visit or hospitalization).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of Age

  Systemic events recorded in an e-diary \& at unscheduled clinical assessments up to Day 7 after Dose 1. Fever: oral temperature \>= 38.0 deg C; categorised as \>=38.0 to 38.4 deg C,\>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite: mild (decreased interest in eating),moderate (decreased oral intake),severe(refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted). Grade 4 for all events: ER visit or hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 1

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of Age

  Systemic events recorded in an e-diary \& at unscheduled clinical assessments up to Day 7 after Dose 2. Fever: oral temperature \>= 38.0 deg C; categorised as \>=38.0 to 38.4 deg C,\>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted). Grade 4 for all events: ER visit or hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 2

• Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of Age

  Systemic events recorded in an e-diary and at unscheduled clinical assessments up to Day 7 after Dose 3. Fever: oral temperature \>= 38.0 deg C; categorised as \>=38.0 to 38.4 deg C,\>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe(disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted). Grade 4 for all events: ER visit or hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.

  Phase 2/3: From Day 1 to Day 7 after Dose 3

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 1 to 1 Month after Dose 2

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 3 to 1 Month after Dose 3

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=5 to <12 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 1 to 6 Months after Dose 2

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 3 to 6 Months after Dose 3

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month from dose 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 1 to 1 Month after Dose 2

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3:>=2 to <5 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 3 to 1 Month after Dose 3

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 1 to 6 Months after Dose 2

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3:>=2 to <5 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 3 to 6 Months after Dose 3

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2 : >=6 Months to <2 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 1 to 1 Month after Dose 2

• Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3 : >=6 Months to <2 Years of Age

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Phase 2/3: From Dose 3 to 1 Month after Dose 3

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=6 Months to <2 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 1 to 6 Months after Dose 2

• Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of Age

  An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Phase 2/3: From Dose 3 to 6 Months after Dose 3

• Phase2/3:Geometric Mean Ratio(GMR)Based on GMT for SARS-CoV-2 Neutralizing Titers in Participants>=5 to<12 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort:1 Month After Dose 2:Participants Without Evidence of Infection

  GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs (based on student t distribution). GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included. GMT is reported in descriptive analysis section and GMR is reported under statistical analysis.

  C4591007 (>=5 to <12 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase 2/3: Difference in Percentage of Participants Who Achieved Seroresponse in >=5 to <12 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection

  Seroresponse is defined as achieving a \>=4 fold rise from baseline (before Dose 1). Assay result below a postvaccination \>=4\*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

  C4591007 (>=5 to <12 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase 2/3: GMR Based on GMT for SARS-CoV-2 Neutralizing Titers in Participants >=2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection

  GMRs \& corresponding 2-sided CIs were calculated by exponentiating mean difference of logarithm of titers \& corresponding CIs(based on student t distribution).GMTs \& 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs(based on the Student t distribution).Assay results below LLOQ were set to 0.5\*LLOQ.Results include those from comparator group of C4591001(NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30mcg who had no serological or virological evidence of past SARS-CoV-2 infection\& had no medical history of COVID-19 were also included.GMT is reported in descriptive analysis section \& GMR is reported under statistical analysis.EIP included all eligible randomized participants who received study intervention to which they were randomized,had a valid\&determinate immunogenicity result within 28-42 days after study vaccination,had no other important protocol deviations as determined by clinician.

  C4591007 (>=2 to <5 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase 2/3: Difference in Percentage of Participants Who Achieved Seroresponse in >=2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection

  Seroresponse is defined as achieving a \>=4-fold rise from baseline (before Dose 1). Assay result below a postvaccination \>=4\*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

  C4591007 (>=2 to <5 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase 2/3: GMR Based on GMT for SARS-CoV-2 Neutralizing Titers in Participants >=6 Months to <2 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection

  GMRs \& corresponding 2-sided CIs were calculated by exponentiating mean difference of logarithm of titers \& corresponding CIs(based on student t distribution).GMTs \& 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs(based on the Student t distribution).Assay results below LLOQ were set to 0.5\*LLOQ.Results include those from comparator group of C4591001(NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30mcg who had no serological or virological evidence of past SARS-CoV-2 infection\& had no medical history of COVID-19 were also included.GMT is reported in descriptive analysis section \& GMR is reported under statistical analysis.EIP included all eligible randomized participants who received study intervention to which they were randomized,had a valid\&determinate immunogenicity result within 28-42 days after study vaccination,had no other important protocol deviations as determined by clinician.

  C4591007 (>=6 Months to <2 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase 2/3: Difference in Percentage of Participants Who Achieved Seroresponse in >=6 Months to <2 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort : 1 Month After Dose 2: Participants Without Evidence of Infection

  Seroresponse is defined as achieving a \>=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination \>=4\*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

  C4591007 (>=6 Months to <2 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase 2/3:GMR Based on GMT for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged>=2 to<5Years Compared With Study C4591001 Phase2/3 16 to 25 Years Historical Cohort(1 Month After Dose 2):Participants Without Evidence of Infection

  GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of logarithm of the titers and the corresponding CIs(based on student t distribution).GMTs \& 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Results include those from comparator group of C4591001 (NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection \& had no medical history of COVID-19 were also included. GMT is reported in descriptive analysis section \& GMR is reported under statistical analysis.

  C4591007 (>=2 to <5 years):1 Month after Dose 2 and C4591001 Historical cohort (16-25 years):1 Month after Dose 2

• Phase 2/3:Difference in Percentage of Participants With Seroresponse in 2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years of Age Historical Cohort: Participants Without Evidence of Infection

  Seroresponse is defined as achieving a \>=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination \>=4\*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

  C4591007 (>=2 to <5 years): 1 Month after Dose 3 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2

• Phase2/3:GMR Based on GMT for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose3 in Participants Aged 6Month to 2Year Compared With Study C4591001 Phase2/3 16 to 25Years Historical Cohort(1 Month After Dose 2):Participants Without Evidence of Infection

  GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of titers and the corresponding CIs (based on student t distribution). GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Results include those from comparator group of C4591001 (NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30mcg who had no serological or virological evidence of past SARS-CoV-2 infection\& had no medical history of COVID-19 were also included. GMT is reported in descriptive analysis section \& GMR is reported under statistical analysis.

  C4591007 (>=6 months to <2 years):1 Month after Dose 3 and C4591001 Historical cohort (16-25 years):1 Month after Dose 2

• Phase 2/3:Difference in Percentage of Participants With Seroresponse in 6 Months to <2 Years (1 Month After Dose 3) Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort (1 Month After Dose 2): Participants Without Evidence of Infection

  Seroresponse is defined as achieving a \>=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination \>=4\*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.

  C4591007 (>=6 Months to <2 years):1 Month after Dose 3 and C4591001 Historical cohort (16-25 years):1 month after Dose 2

Secondary Outcomes (15)

• Phase 1: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=6 Months to <2 Years of Age: Participants Without Evidence of Infection

  Phase 1: 7 days post Dose 2

• Phase 1: GMT of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=2 to <5 Years of Age: Participants Without Evidence of Infection

  Phase 1: 7 days post Dose 2

• Phase 1: GMT of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=5 to <12 Years of Age: Participants Without Evidence of Infection

  Phase 1: 7 days post Dose 2

• Phase 2/3: Geometric Mean Titer - Neutralizing Titer (NT50) : 5 to <12 Years of Age: Before Dose 1 and 1 Month After Dose 2:Participants Without Evidence of Infection

  Phase 2/3: Before Dose 1 and 1 Month after Dose 2

• Phase 2/3: Geometric Mean Titer - NT50: 5 to <12 Years of Age: Pre-Dose 3 and 1 Month After Dose 3:Participants Without Evidence of Infection

  Phase 2/3: From Dose 3 set: Pre-Dose 3 and 1 Month after Dose 3

Study Arms (21)

Low/Mid-Dose, ≥5 to <12 Years

EXPERIMENTAL

Low/Mid-Dose (10mcg), 2 doses 21 days apart

Biological: Biological/Vaccine: BNT162b2 10mcg

Mid-Dose, ≥5 to <12 Years

EXPERIMENTAL

Mid-Dose, (20mcg), 2 doses 21 days apart

Biological: BNT162b2 20mcg

High-Dose, ≥5 to <12 Years

EXPERIMENTAL

High-Dose (30mcg), 2 doses 21 days apart

Biological: BNT162b2 30mcg

Low/Mid-Dose, ≥2 to < 5 Years

EXPERIMENTAL

Low/Mid-Dose (10mcg), 2 doses 21 days apart

Biological: Biological/Vaccine: BNT162b2 10mcg

Mid-Dose, ≥2 to <5 Years

EXPERIMENTAL

Mid-Dose, (20mcg), 2 doses 21 days apart

Biological: BNT162b2 20mcg

High-Dose, ≥2 to <5 Years

EXPERIMENTAL

High-Dose, (30mcg), 2 doses 21 days apart

Biological: BNT162b2 30mcg

Low/Mid-Dose, ≥6 Months to <2 Years

EXPERIMENTAL

Low/Mid-Dose, (10mcg), 2 doses 21 days apart

Biological: Biological/Vaccine: BNT162b2 10mcg

Mid-Dose, ≥6 Months to <2 Years

EXPERIMENTAL

Mid-Dose, (20mcg), 2 doses 21 days apart

Biological: BNT162b2 20mcg

High-Dose, ≥6 Months to <2 Years

EXPERIMENTAL

High-Dose, (30mcg), 2 doses 21 days apart

Biological: BNT162b2 30mcg

Placebo, ≥6 Months to <2 Years

PLACEBO COMPARATOR

Other: Placebo

Placebo, ≥2 to <5 Years

PLACEBO COMPARATOR

Other: Placebo

Placebo, ≥5 to <12 Years

PLACEBO COMPARATOR

Other: Placebo

Low-Dose, ≥6 Months to <2 Years

EXPERIMENTAL

Low-Dose (3mcg), 2 doses 21 doses apart

Biological: Biological/Vaccine: BNT162b2 3mcg

Low-Dose, ≥2 to <5 Years

EXPERIMENTAL

Low-Dose (3mcg), 2 doses 21 days apart

Biological: Biological/Vaccine: BNT162b2 3mcg

High-Dose, 12 to <16 Years (Troponin I Testing)

EXPERIMENTAL

High-Dose (30mcg), 3 doses

Biological: BNT162b2 30mcg

Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing)

EXPERIMENTAL

Low/Mid-Dose (10mcg), 3 doses

Biological: Biological/Vaccine: BNT162b2 10mcg

Placebo, ≥5 to <12 Years (Troponin I Testing)

EXPERIMENTAL

Other: Placebo

Low-Dose, ≥6 Months to <2 Years (3-dose regimen)

EXPERIMENTAL

Low-Dose (3mcg), 3 doses

Biological: Biological/Vaccine: BNT162b2 3mcg

Low-Dose, ≥2 to <5 Years (3-dose regimen)

EXPERIMENTAL

Low-Dose (3mcg), 3 doses

Biological: Biological/Vaccine: BNT162b2 3mcg

Placebo, ≥6 Months to <2 Years (3-dose regimen)

PLACEBO COMPARATOR

Other: Placebo

Placebo, ≥2 to <5 Years (3-dose regimen)

PLACEBO COMPARATOR

Other: Placebo

Interventions

Biological/Vaccine: BNT162b2 10mcg BIOLOGICAL

BNT162b2 Low/Mid-Dose (10mcg) level

Low/Mid-Dose, ≥2 to < 5 Years; Low/Mid-Dose, ≥5 to <12 Years; Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing); Low/Mid-Dose, ≥6 Months to <2 Years

BNT162b2 20mcg BIOLOGICAL

BNT162b2 Mid-Dose (20mcg) level

Mid-Dose, ≥2 to <5 Years; Mid-Dose, ≥5 to <12 Years; Mid-Dose, ≥6 Months to <2 Years

BNT162b2 30mcg BIOLOGICAL

BNT162b2 High-Dose (30mcg) level

High-Dose, 12 to <16 Years (Troponin I Testing); High-Dose, ≥2 to <5 Years; High-Dose, ≥5 to <12 Years; High-Dose, ≥6 Months to <2 Years

Placebo OTHER

Intramuscular injection

Placebo, ≥2 to <5 Years; Placebo, ≥2 to <5 Years (3-dose regimen); Placebo, ≥5 to <12 Years; Placebo, ≥5 to <12 Years (Troponin I Testing); Placebo, ≥6 Months to <2 Years; Placebo, ≥6 Months to <2 Years (3-dose regimen)

Biological/Vaccine: BNT162b2 3mcg BIOLOGICAL

BNT162b2 Low-Dose (3mcg) level

Low-Dose, ≥2 to <5 Years; Low-Dose, ≥2 to <5 Years (3-dose regimen); Low-Dose, ≥6 Months to <2 Years; Low-Dose, ≥6 Months to <2 Years (3-dose regimen)

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female participants ≥6 months to \<12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and \<16 years of age.
• Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
• Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
• Negative urine pregnancy test for female participants who are biologically capable of having children.
• Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
• The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).

You may not qualify if:

• Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
• Phase 1 only: Known infection with HIV, HCV, or HBV.
• Receipt of medications intended to prevent COVID-19.
• Previous or current diagnosis of MIS-C.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Female who is pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
• Previous participation in other studies involving study intervention containing LNPs.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (128)

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, 35233, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

SCPMG/Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Kaiser Permanente Oakland

Oakland, California, 94611, United States

Location

Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University

Palo Alto, California, 94304, United States

Location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Center for Clinical Trials

Paramount, California, 90723, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Kaiser Permanente Sacramento

Sacramento, California, 95815, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

Stanford Health Care Investigational Drug Service

Stanford, California, 94305, United States

Location

Stanford Health Care

Stanford, California, 94305, United States

Location

Bayview Research Group, LLC

Valley Village, California, 91607, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Emory Children's Center Illness POD

Atlanta, Georgia, 30322, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Meridian Clinical Research, LLC

Macon, Georgia, 31210, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Novak Center for Children's Health

Louisville, Kentucky, 40202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, 71101, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Michigan Center of Medical Research

Bingham Farms, Michigan, 48025, United States

Location

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Meridian Clinical Research, LLC

Hastings, Nebraska, 68901, United States

Location

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States

Location

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

Children's Physician's Clinic, Spring Valley

Omaha, Nebraska, 68117, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Meridian Clinical Research LLC

Binghamton, New York, 13905, United States

Location

Advanced Specialty Care

Commack, New York, 11725, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Atrium Health-STRIVE Vaccine Research Clinic

Charlotte, North Carolina, 28207, United States

Location

Teen Health Connection (study visits)

Charlotte, North Carolina, 28211, United States

Location

Duke University - Main Hospital and Clinics

Durham, North Carolina, 27703, United States

Location

Atrium Health-STRIVE Vaccine Research Clinic (study visits)

Matthews, North Carolina, 28105, United States

Location

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, 45229, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45429, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

AHN Erie Health + Wellness Pavillion: West

Erie, Pennsylvania, 16506, United States

Location

Velocity Clinical Research-Providence

East Greenwich, Rhode Island, 02818, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

Innovo Research - Austin Regional Clinic

Austin, Texas, 78726, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Cedar Health Research

Dallas, Texas, 75251, United States

Location

Bay Colony Pediatrics

Dickinson, Texas, 77539, United States

Location

Proactive Clinical Research, LLC

Edinburg, Texas, 78539, United States

Location

Village Health Partners (Patient Seen Address)

Frisco, Texas, 75033, United States

Location

Helios Clinical Research - HOU

Houston, Texas, 77008, United States

Location

Helios Clinical Research

Houston, Texas, 77008, United States

Location

HG Pediatrics

Houston, Texas, 77008, United States

Location

Van Tran Family Practice

Houston, Texas, 77008, United States

Location

Texas Children's Hospital - Clinical Research Center

Houston, Texas, 77030, United States

Location

West Houston Clinical Research Services

Houston, Texas, 77055, United States

Location

DM Clinical Research - MDC

Houston, Texas, 77065, United States

Location

Pediatric Associates

Houston, Texas, 77087, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Charlottesville, Virginia, 22902, United States

Location

Virginia Research Center

Midlothian, Virginia, 23114, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC

Salvador, Estado de Bahia, 40415-006, Brazil

Location

Santa Casa De Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil

Location

CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Natal, Rio Grande do Norte, 59025-050, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.

São Paulo, 04266-010, Brazil

Location

FVR, Oulu Clinic

Oulu, North Ostrobothnia, 90220, Finland

Location

FVR, Järvenpää Clinic

Jarvenpaa, Uusimaa, 04400, Finland

Location

FVR, Espoo Clinic

Espoo, 02230, Finland

Location

FVR, Helsinki South Clinic

Helsinki, 00100, Finland

Location

MeVac - Meilahti Vaccine Research Center

Helsinki, 00290, Finland

Location

FVR, Helsinki East Clinic

Helsinki, 00930, Finland

Location

FVR, Kokkola Clinic

Kokkola, 67100, Finland

Location

FVR, Pori Clinic

Pori, 28100, Finland

Location

FVR, Seinäjoki Clinic

Seinäjoki, 60100, Finland

Location

FVR, Tampere Clinic

Tampere, 33100, Finland

Location

FVR, Turku Clinic

Turku, 20520, Finland

Location

CHRISTUS - LATAM HUB Center of excellence and innovation S.C.

Monterrey, Nuevo León, C.P. 64060, Mexico

Location

Kohler & Milstein Research S.A. de C.V.

Mérida, Yucatán, 97070, Mexico

Location

Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion

Mérida, Yucatán, 97130, Mexico

Location

Sociedad de Metabolismo y Corazón S.C.

Veracruz, C.P. 91900, Mexico

Location

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

IN-VIVO Bydgoszcz

Bydgoszcz, 85-048, Poland

Location

Centrum Badan Klinicznych JCI

Krakow, 30-348, Poland

Location

Osrodek Badan Klinicznych Appletreeclinics

Lodz, 90-349, Poland

Location

GRAVITA Diagnostyka i Leczenie nieplodnosci

Lodz, 91-347, Poland

Location

Rodzinne Centrum Medyczne LUBMED

Luboń, 62-030, Poland

Location

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, 41-103, Poland

Location

Provita 001

Warsaw, 02-647, Poland

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

EBA Centelles

Centelles, Barcelona, 08540, Spain

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad de, 28938, Spain

Location

Hospital de Antequera

Antequera, Málaga, 29200, Spain

Location

Grupo Pediatrico Uncibay

Málaga, Málaga, 29015, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Instituto Hispalense de Pediatria

Seville, 41012, Spain

Location

Related Publications (4)

• Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.

  PMID: 39197299 DERIVED

• Simoes EAF, Klein NP, Sabharwal C, Gurtman A, Kitchin N, Ukkonen B, Korbal P, Zou J, Xie X, Sarwar UN, Xu X, Lockhart S, Cunliffe L, Lu C, Ma H, Swanson KA, Koury K, Shi PY, Cooper D, Tureci Ӧ, Jansen KU, Sahin U, Gruber WC. Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds. J Pediatric Infect Dis Soc. 2023 Apr 28;12(4):234-238. doi: 10.1093/jpids/piad015.

  PMID: 36929216 DERIVED

• Munoz FM, Sher LD, Sabharwal C, Gurtman A, Xu X, Kitchin N, Lockhart S, Riesenberg R, Sexter JM, Czajka H, Paulsen GC, Maldonado Y, Walter EB, Talaat KR, Englund JA, Sarwar UN, Hansen C, Iwamoto M, Webber C, Cunliffe L, Ukkonen B, Martinez SN, Pahud BA, Munjal I, Domachowske JB, Swanson KA, Ma H, Koury K, Mather S, Lu C, Zou J, Xie X, Shi PY, Cooper D, Tureci O, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age. N Engl J Med. 2023 Feb 16;388(7):621-634. doi: 10.1056/NEJMoa2211031.

  PMID: 36791162 DERIVED

• Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Munoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simoes EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Ramet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Tureci O, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022 Jan 6;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 9.

  PMID: 34752019 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19

Interventions

Biological Products; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: BioNTech clinical trials patient information
• Organization: BioNTech SE

patients@biontech.de

+49 6131 90840

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: March 24, 2021
• Primary Completion: October 4, 2023
• Study Completion: December 8, 2023
• Last Updated: May 28, 2026
• Results First Posted: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); BR (5); US (90); FI (11); ME (4); PL (8)