20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

NCT04546425 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B74710122019-003306-27
• Study Type: interventional
• Target: 1,258
• Locations: 12 countries
• Sites: 66

Brief Summary

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (31)

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

  Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.

  Within 7 days after Dose 1

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

  Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

  Within 7 days after Dose 2

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

  Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

  Within 7 days after Dose 3

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

  Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  Within 7 Days after Dose 1

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

  Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  Within 7 Days after Dose 2

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

  Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) \& severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  Within 7 Days after Dose 3

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

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

  From Dose 1 to 1 month after Dose 2

• Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

  From Dose 3 to 1 month after Dose 3

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

  A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

  From Dose 1 to 1 month after Dose 3

• Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population

  A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

  From Dose 1 to 1 month after Dose 3

• Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population

  Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per mL (mcg/mL), for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

  1 month after Dose 2

• Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population

  Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Assay result below LLOQ was set to 0.5\*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).

  1 month after Dose 2

• GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population

  Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5\*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).

  1 month after Dose 3

• Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population

  Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units \[IU\]) to diphtheria \& tetanus toxoid (prespecified level\>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level \>=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level \>=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: \>=1:8; Hemophilus influenzae type b(Hib): prespecified level \>=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.

  1 month after Dose 3

• GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population

  Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

  1 month after Dose 3

• GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population

  Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

  1 month after Dose 3

• GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population

  Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

  1 month after Dose 3

• GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population

  Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.

  1 month after Dose 3

• Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort

  Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

  Within 7 days after Dose 1

• Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort

  Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

  Within 7 days after Dose 2

• Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort

  Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.

  Within 7 days after Dose 3

• Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort

  Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature \>=38.0 degree C \& categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

  Within 7 Days after Dose 1

• Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort

  Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

  Within 7 Days after Dose 2

• Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort

  Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.

  Within 7 Days after Dose 3

• Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

  From Dose 1 to 1 month after Dose 2

• Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort

  An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.

  From Dose 3 to 1 month after Dose 3

• Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort

  A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

  From Dose 1 to 1 month after Dose 3

• Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort

  A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

  From Dose 1 to 1 month after Dose 3

• Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort

  Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B. \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.

  1 month after Dose 2

• GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort

  Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).

  1 month after Dose 2

• GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort

  Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).

  1 month after Dose 3

Secondary Outcomes (8)

• Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population

  1 Month after Dose 3

• Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population

  1 month after Dose 2

• Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population

  1 Month after Dose 3

• Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population

  Before Dose 3 to 1 month after Dose 3

• Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population

  1 month after Dose 2

Study Arms (2)

20-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Pneumococcal conjugate vaccine

Biological: 20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

ACTIVE COMPARATOR

Pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

20-valent pneumococcal conjugate vaccine BIOLOGICAL

20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 42 Days - 112 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

You may not qualify if:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
• Major known congenital malformation or serious chronic disorder.
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (66)

Perth Children's Hospital

Nedlands, Western Australia, 6009, Australia

Location

Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital

Nedlands, Western Australia, 6009, Australia

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

DD ordinace s.r.o.

Jindřichův Hradec, 377 01, Czechia

Location

Ordinace praktického lékaře pro děti a dorost

Jindřichův Hradec, 377 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 377 01, Czechia

Location

Zdravotnicke stredisko Dubina, verejna obchodni spolecnost

Pardubice, 530 12, Czechia

Location

MUDr. Jitka Fabianova

Prague, 130 00, Czechia

Location

MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost

Prague, 160 00, Czechia

Location

Medicentrum 6 s.r.o.

Prague, 160 00, Czechia

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Kadrina Tervisekeskus OU

Kadrina, 45201, Estonia

Location

Merekivi Perearstid.

Tallinn, 10617, Estonia

Location

Merelahe Family Doctors Centre

Tallinn, 10617, Estonia

Location

OU Al Mare Perearstikeskus

Tallinn, 10617, Estonia

Location

Sinu Arst Health Center

Tallinn, 11313, Estonia

Location

Clinical Research Centre

Tartu, 50106, Estonia

Location

Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

Helsinki South Vaccine Research Clinic

Helsinki, 00100, Finland

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

FVR, Oulun rokotetutkimusklinikka

Oulu, 90220, Finland

Location

Tampereen yliopisto Oulun Rokotetutkimusklinikka

Oulu, 90220, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Seinäjoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

Tampere Vaccine Research Center

Tampere, 33100, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura

Milan, Milan, 20122, Italy

Location

Azienda Ospedaliero Universitaria Meyer

Florence, 50139, Italy

Location

Azienda Ospedaliera Universitaria

Foggia, 71122, Italy

Location

Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Stichting Apotheek der Haarlemse Ziekenhuizen

Haarlem, 2035 RC, Netherlands

Location

Spaarne Gasthuis (Kennemer Gasthuis)

Hoofddorp, 2134 TM, Netherlands

Location

Akershus University Hospital

Lorenskog, 1478, Norway

Location

Oslo University Hospital, Ulleval

Oslo, 0450, Norway

Location

Stavanger University Hospital

Stavanger, 4011, Norway

Location

Akershus University Hospital - Sykehusapoteket Ahus

Viken, 1474, Norway

Location

IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz

Bydgoszcz, 85-048, Poland

Location

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek

Dębica, 39-200, Poland

Location

Centrum Badan Klinicznych JCI

Krakow, 30-348, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej

Krakow, 31-202, Poland

Location

GRAVITA. Diagnostyka i Leczenie nieplodnosci

Lodz, 91-347, Poland

Location

Rodzinne Centrum Medyczne LUBMED

Luboń, 62-030, Poland

Location

Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu

Poznan, 60-663, Poland

Location

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, 41-103, Poland

Location

Nasz Lekarz Przychodnie Medyczne Slawomir Jeka

Torun, 87-100, Poland

Location

Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

Trzebnica, 55-100, Poland

Location

Szpital Bielanski im. ks. J. Popieluszki SPZOZ

Warsaw, 01-809, Poland

Location

Provita 001

Warsaw, 02-647, Poland

Location

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-368, Poland

Location

Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny

Wroclaw, 51-141, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"

Łęczna, 21-010, Poland

Location

Federal State Budget Institution of Healthcare Central clinical hospital of Russian

Moscow, 119333, Russia

Location

State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"

Perm, 614066, Russia

Location

LLC PiterClinica

Saint Petersburg, 196158, Russia

Location

State autonomous institution of healthcare of Sverdlovsk region

Yekaterinburg, 620028, Russia

Location

PEDIAMED s.r.o.

Bratislava, 831 03, Slovakia

Location

NASA DOKTORKA s.r.o.

Bratislava, 841 02, Slovakia

Location

Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.

Detva, 962 12, Slovakia

Location

MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast

Horné Srnie, 91442, Slovakia

Location

Všeobecná ambulancia pre deti a dorast

Humenné, 06601, Slovakia

Location

PEDAMB s.r.o.

Košice, 040 11, Slovakia

Location

MUDr. Drusková s.r.o.

Liptovská Osada, 034 73, Slovakia

Location

Related Publications (2)

• Senders S, Korbal P, Kline M, Tamimi N, Thompson A, Drozd J, Cutler MW, Giardina PC, Trammel J, Lei L, Peng Y, Watson W, McElwee K. Immunogenicity and safety of concomitant vaccines given with 20-valent pneumococcal conjugate vaccine in healthy infants. Vaccine. 2025 Dec 5;68:127916. doi: 10.1016/j.vaccine.2025.127916. Epub 2025 Nov 3.

  PMID: 41187484 DERIVED

• Korbal P, Wysocki J, Jackowska T, Kline M, Tamimi N, Drozd J, Lei L, Peng Y, Giardina PC, Gruber W, Scott D, Watson W. Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. Pediatr Infect Dis J. 2024 Jun 1;43(6):587-595. doi: 10.1097/INF.0000000000004300. Epub 2024 Mar 8.

  PMID: 38456705 DERIVED

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 14, 2020
• Study Start: September 9, 2020
• Primary Completion: April 22, 2022
• Study Completion: February 18, 2023
• Last Updated: January 8, 2024
• Results First Posted: May 15, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

SL (7); BE (2); PL (16); RU (4); AU (2); CZ (7); ES (6); IT (4); FI (11); NL (2); DK (1); NO (4)