A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

NCT04713553 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: C4591017
• Study Type: interventional
• Target: 1,574
• Locations: 1 country
• Sites: 17

Brief Summary

This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2):

• As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
• As a 20-microgram dose, administered from 1 of the manufacturing lots
• As a 2-dose (separated by 21 days) schedule
• In people 12 through 50 years of age The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):
• Each as a 30-microgram dose
• Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2
• In people 18 through 50 years of age

Conditions

SARS-CoV-2 Infection; COVID-19

Keywords

COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine; BNT162b2; BNT162B2.1.B.351

Outcome Measures

Primary Outcomes (48)

• Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study

  Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.

  1 Month after Dose 2

• Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study

  Geometric mean concentration of full-length S-binding IgG level for EU lot and pooled US lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm) were determined and reported in the descriptive section. Assay results below the LLOQ were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratios of GMCs of BNT162b2 30 mcg: EU Lot and pooled US Lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm).

  1 Month after Dose 2

• Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study

  Geometric mean titer for SARS-CoV-2 neutralizing titers for 20 mcg dose and 30 mcg dose of US Lot 1 was determined and reported in the descriptive section. GMTs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) mean of the titers and corresponding CIs based on linear regression model. Assay results below the LLOQ were set to 0.5\*LLOQ. GMRs were reported in the statistical analysis section and were calculated as the ratio of geometric mean titer of the 20-mcg dose (US Lot 1) to the geometric mean titer of the 30 mcg dose (US Lot 1).

  1 Month after Dose 2

• Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study

  Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 1. Redness, swelling, and pain at injection site after Dose 1 were reported.

  Within 7 days after Dose 1

• Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study

  Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 2. Redness, swelling, and pain at injection site after Dose 2 were reported.

  Within 7 days after Dose 2

• Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study

  Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. Redness, swelling, and pain at injection site after any dose were reported.

  Within 7 days after any dose

• Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study

  Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. Redness, swelling, and pain at injection site after Dose 3 were reported.

  Within 7 days after Dose 3

• Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study

  Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 1 were reported.

  Within 7 days after Dose 1

• Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study

  Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 C and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 2 were reported.

  Within 7 days after Dose 2

• Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study

  Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 C and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after any dose were reported.

  Within 7 days after any dose

• Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study

  Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 C and categorized as \>=38.0 to 38.4 C; \>38.4 to 38.9 C; \>38.9 to 40.0 C; \>40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 3 were reported.

  Within 7 days after Dose 3

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

  Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

  From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days)

• Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  Baseline (prior to Dose 1 of Primary study)

• Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  1 Month after Dose 2 of primary study

• Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  Before Dose 3

• Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  1 Week after Dose 3

• Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  1 Month after Dose 3

• Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster Study

  GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

  Baseline (prior to Dose 1 of Primary study)

• Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster Study

  GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

  1 Month after Dose 2 of primary study

• Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  Before Dose 3

• Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  1 Week after Dose 3

• Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study

  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 LLOQ were set to 0.5 × LLOQ.

  1 Month after Dose 3

• Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study

  GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Baseline (prior to Dose 1 of Primary study)

• Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study

  GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  1 Month after Dose 2 of primary study

• Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study

  GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3

• Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study

  GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  1 Week after Dose 3

• Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study

  GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  1 Month after Dose 3

• Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  From 1 Month after Dose 2 to 1 Week after Dose 3

• Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  From 1 Month after Dose 2 to 1 Month after Dose 3

• Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3 to 1 Week after Dose 3

• Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3 to 1 Month after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  From 1 Month after Dose 2 to 1 Week after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  From 1 Month after Dose 2 to 1 Month after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3 to 1 Week after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3 to 1 Month after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

  From 1 Month after Dose 2 to 1 Week after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

  From 1 Month after Dose 2 to 1 Month after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3 to 1 Week after Dose 3

• Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study

  GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.

  Before Dose 3 to 1 Month after Dose 3

• Percentage of Participants With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study

  Seroresponse was defined as greater than equal to (\>=) 4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  1 Month after Dose 2

• Percentage of Participants With Seroresponse to Reference Strain Before Dose 3: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Before Dose 3

• Percentage of Participants With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  1 Week after Dose 3

• Percentage of Participants With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of \>=4\*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  1 Month after Dose 3

• Percentage of Participants With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  1 Month after Dose 2

• Percentage of Participants With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  Before Dose 3

• Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  1 Week after Dose 3

• Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study

  Seroresponse was defined as \>=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  1 Month after Dose 3

Secondary Outcomes (4)

• Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study

  Baseline (before Dose 1), 1 Month after Dose 2

• Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study

  From Baseline (before Dose 1) up to 1 Month after Dose 2

• Geometric Mean Titers (GMT) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study

  Baseline (before Dose 1), 1 Month after Dose 2

• Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study

  From Baseline (before Dose 1) up to 1 Month after Dose 2

Study Arms (7)

Arm 1

EXPERIMENTAL

30-microgram dose of US manufactured drug substance (Lot 1)

Biological: BNT162b2

Arm 2

EXPERIMENTAL

30-microgram dose of US manufactured drug substance (Lot 2)

Biological: BNT162b2

Arm 3

EXPERIMENTAL

30-microgram dose of US manufactured drug substance (Lot 3)

Biological: BNT162b2

Arm 4

EXPERIMENTAL

30-microgram dose of EU manufactured drug substance (Lot 4)

Biological: BNT162b2

Arm 5

EXPERIMENTAL

20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)

Biological: BNT162b2

Booster 1: BNT162b2

EXPERIMENTAL

30-microgram dose

Biological: BNT162b2

Booster 2: BNT162b2.B.1.351

EXPERIMENTAL

30-microgram dose

Biological: BNT162b2.B.1.351

Interventions

BNT162b2 BIOLOGICAL

Intramuscular injection

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Booster 1: BNT162b2

BNT162b2.B.1.351 BIOLOGICAL

Intramuscular injection

Booster 2: BNT162b2.B.1.351

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
• Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.

You may not qualify if:

• 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.
• Known infection with HIV, HCV, or HBV.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
• Previous 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.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Primary study: Previous vaccination with any coronavirus vaccine.
• Booster study: Previous vaccination with any coronavirus vaccine outside of this study.
• Receipt of medications intended to prevent COVID-19.
• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
• Receipt of blood/plasma products or immunoglobulin, from 60 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 lipid nanoparticles.
• Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (17)

Kaiser Permanente Oakland

Oakland, California, 94611, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Amici Clinical Research LLC

Raritan, New Jersey, 08869, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

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

Salt Lake City, Utah, 84121, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; 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 9084

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: February 15, 2021
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)