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

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

42 Days - 112 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Perth Children's Hospital
  • Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital
  • Cliniques Universitaires Saint-Luc
  • University Hospital Antwerp
  • DD ordinace s.r.o.
  • Ordinace praktického lékaře pro děti a dorost
  • Samostatna ordinace praktickeho lekare pro deti a dorost
  • Zdravotnicke stredisko Dubina, verejna obchodni spolecnost
  • MUDr. Jitka Fabianova
  • MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
  • Medicentrum 6 s.r.o.
  • Hvidovre Hospital
  • Kadrina Tervisekeskus OU
  • Merekivi Perearstid.
  • Merelahe Family Doctors Centre
  • OU Al Mare Perearstikeskus
  • Sinu Arst Health Center
  • Clinical Research Centre
  • Espoo Vaccine Research Clinic
  • Helsinki South Vaccine Research Clinic
  • Helsinki East Vaccine Research Clinic
  • Jarvenpaa Vaccine Research Clinic
  • Kokkola Vaccine Research Clinic
  • FVR, Oulun rokotetutkimusklinikka
  • Tampereen yliopisto Oulun Rokotetutkimusklinikka
  • Pori Vaccine Research Clinic
  • Seinäjoki Vaccine Research Clinic
  • Tampere Vaccine Research Center
  • Turku Vaccine Research Clinic
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura
  • Azienda Ospedaliero Universitaria Meyer
  • Azienda Ospedaliera Universitaria
  • Ospedale Policlinico San Martino
  • Stichting Apotheek der Haarlemse Ziekenhuizen
  • Spaarne Gasthuis (Kennemer Gasthuis)
  • Akershus University Hospital
  • Oslo University Hospital, Ulleval
  • Stavanger University Hospital
  • Akershus University Hospital - Sykehusapoteket Ahus
  • IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz
  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
  • Centrum Badan Klinicznych JCI
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej
  • Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"
  • GRAVITA. Diagnostyka i Leczenie nieplodnosci
  • Rodzinne Centrum Medyczne LUBMED
  • Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
  • Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
  • Nasz Lekarz Przychodnie Medyczne Slawomir Jeka
  • Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
  • Szpital Bielanski im. ks. J. Popieluszki SPZOZ
  • Provita 001
  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
  • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
  • State autonomous institution of healthcare of Sverdlovsk region
  • Federal State Budget Institution of Healthcare Central clinical hospital of Russian
  • State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"
  • LLC PiterClinica
  • PEDIAMED s.r.o.
  • NASA DOKTORKA s.r.o.
  • Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.
  • MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast
  • Všeobecná ambulancia pre deti a dorast
  • PEDAMB s.r.o.
  • MUDr. Drusková s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Arm Description

Pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Outcomes

Primary Outcome Measures

Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/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.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/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.
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/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.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events included 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 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than >=38.0 degrees C and categorized to >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >=38.0 degrees C and categorized to >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2
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.
Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3
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.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 1
An SAE was any untoward medical occurrence that occurred, 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.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3
An 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.
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2
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.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2
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. GMCs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution). GMRs were reported in statistical analysis section and were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3
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. GMCs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3
Vaccines administered concomitantly with 20vPnC or 13vPnC, responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration (conc.) of antibody (in international units [IU]) to diphtheria and tetanus toxoid (prespecified level >= 0.1 IU/mL); Acellular pertussis IgG conc. of pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN) (prespecified level>=observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Hepatitis B: conc. of hepatitis B antibody (in milli-IU per mL [mIU/mL]) (prespecified level >=10mIU/mL); Poliomyelitis: neutralizing antibody (NA) titers to poliovirus types 1, 2, and 3 (prespecified level NA titer >= 1:8); and Haemophilus influenzae type b (Hib): conc. of antibody to Hib (polyribosylribitol phosphate [PRP]) in mcg/mL (prespecified level >=0.15 mcg/mL anti-PRP). 2-sided 95% CI based on Clopper and Pearson method. Assays were performed on randomly selected subsets.
GMC of Measles Virus Antibody 1 Month After Dose 3
Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
GMC of Mumps Virus Antibody 1 Month After Dose 3
Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
GMC of Rubella Virus Antibody 1 Month After Dose 3
Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
GMC of Varicella Virus Antibody 1 Month After Dose 3
Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.

Secondary Outcome Measures

Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3
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.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
GMTs of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. OPA titers performed on randomly selected subsets.
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2
Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration (conc.) of antibody(in international units [IU]) to diphtheria and tetanus toxoid(prespecified level >= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer >=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level >=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.

Full Information

First Posted
August 21, 2020
Last Updated
June 1, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04546425
Brief Title
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
February 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine
Arm Title
13-valent pneumococcal conjugate vaccine
Arm Type
Active Comparator
Arm Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
20-valent pneumococcal conjugate vaccine
Intervention Description
20-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
13-valent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Description
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/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.
Time Frame
Within 7 days after Dose 1
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Description
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/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.
Time Frame
Within 7 days after Dose 2
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Description
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/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.
Time Frame
Within 7 days after Dose 3
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Description
Systemic events included 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 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame
Within 7 Days after Dose 1
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Description
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than >=38.0 degrees C and categorized to >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame
Within 7 Days after Dose 2
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Description
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >=38.0 degrees C and categorized to >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees 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 or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame
Within 7 Days after Dose 3
Title
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2
Description
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.
Time Frame
From Dose 1 to 1 month after Dose 2
Title
Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3
Description
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.
Time Frame
From Dose 3 to 1 month after Dose 3
Title
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 1
Description
An SAE was any untoward medical occurrence that occurred, 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.
Time Frame
From Dose 1 to 1 month after Dose 1
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3
Description
An 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.
Time Frame
From Dose 1 to 1 month after Dose 3
Title
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2
Description
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.
Time Frame
1 month after Dose 2
Title
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2
Description
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. GMCs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution). GMRs were reported in statistical analysis section and were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Time Frame
1 month after Dose 2
Title
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3
Description
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. GMCs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Time Frame
1 month after Dose 3
Title
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3
Description
Vaccines administered concomitantly with 20vPnC or 13vPnC, responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration (conc.) of antibody (in international units [IU]) to diphtheria and tetanus toxoid (prespecified level >= 0.1 IU/mL); Acellular pertussis IgG conc. of pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN) (prespecified level>=observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Hepatitis B: conc. of hepatitis B antibody (in milli-IU per mL [mIU/mL]) (prespecified level >=10mIU/mL); Poliomyelitis: neutralizing antibody (NA) titers to poliovirus types 1, 2, and 3 (prespecified level NA titer >= 1:8); and Haemophilus influenzae type b (Hib): conc. of antibody to Hib (polyribosylribitol phosphate [PRP]) in mcg/mL (prespecified level >=0.15 mcg/mL anti-PRP). 2-sided 95% CI based on Clopper and Pearson method. Assays were performed on randomly selected subsets.
Time Frame
1 month after Dose 3
Title
GMC of Measles Virus Antibody 1 Month After Dose 3
Description
Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
Time Frame
1 month after Dose 3
Title
GMC of Mumps Virus Antibody 1 Month After Dose 3
Description
Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
Time Frame
1 month after Dose 3
Title
GMC of Rubella Virus Antibody 1 Month After Dose 3
Description
Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
Time Frame
1 month after Dose 3
Title
GMC of Varicella Virus Antibody 1 Month After Dose 3
Description
Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses measured 1 month after Dose 3. Assay results below the lower limit of quantitation (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 assays were performed on randomly selected subsets.
Time Frame
1 month after Dose 3
Secondary Outcome Measure Information:
Title
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3
Description
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.
Time Frame
1 Month after Dose 3
Title
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2
Description
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Time Frame
1 month after Dose 2
Title
GMTs of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3
Description
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. OPA titers performed on randomly selected subsets.
Time Frame
1 Month after Dose 3
Title
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3
Description
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Time Frame
1 month after Dose 3
Title
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2
Description
Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration (conc.) of antibody(in international units [IU]) to diphtheria and tetanus toxoid(prespecified level >= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer >=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level >=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.
Time Frame
1 month after Dose 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
112 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
DD ordinace s.r.o.
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
Ordinace praktického lékaře pro děti a dorost
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
Samostatna ordinace praktickeho lekare pro deti a dorost
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
Zdravotnicke stredisko Dubina, verejna obchodni spolecnost
City
Pardubice
ZIP/Postal Code
530 12
Country
Czechia
Facility Name
MUDr. Jitka Fabianova
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Medicentrum 6 s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Kadrina Tervisekeskus OU
City
Kadrina
ZIP/Postal Code
45201
Country
Estonia
Facility Name
Merekivi Perearstid.
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Merelahe Family Doctors Centre
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
OU Al Mare Perearstikeskus
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Sinu Arst Health Center
City
Tallinn
ZIP/Postal Code
11313
Country
Estonia
Facility Name
Clinical Research Centre
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Facility Name
Espoo Vaccine Research Clinic
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
Helsinki South Vaccine Research Clinic
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Helsinki East Vaccine Research Clinic
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Jarvenpaa Vaccine Research Clinic
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
Kokkola Vaccine Research Clinic
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
FVR, Oulun rokotetutkimusklinikka
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Tampereen yliopisto Oulun Rokotetutkimusklinikka
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Pori Vaccine Research Clinic
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Seinäjoki Vaccine Research Clinic
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampere Vaccine Research Center
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Turku Vaccine Research Clinic
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura
City
Milano
State/Province
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Stichting Apotheek der Haarlemse Ziekenhuizen
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Spaarne Gasthuis (Kennemer Gasthuis)
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo University Hospital, Ulleval
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Akershus University Hospital - Sykehusapoteket Ahus
City
Viken
ZIP/Postal Code
1474
Country
Norway
Facility Name
IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
Centrum Badan Klinicznych JCI
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
GRAVITA. Diagnostyka i Leczenie nieplodnosci
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Rodzinne Centrum Medyczne LUBMED
City
Lubon
ZIP/Postal Code
62-030
Country
Poland
Facility Name
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
City
Poznan
ZIP/Postal Code
60-663
Country
Poland
Facility Name
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
Nasz Lekarz Przychodnie Medyczne Slawomir Jeka
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Szpital Bielanski im. ks. J. Popieluszki SPZOZ
City
Warszawa
ZIP/Postal Code
01-809
Country
Poland
Facility Name
Provita 001
City
Warszawa
ZIP/Postal Code
02-647
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
City
Wroclaw
ZIP/Postal Code
51-141
Country
Poland
Facility Name
State autonomous institution of healthcare of Sverdlovsk region
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Federal State Budget Institution of Healthcare Central clinical hospital of Russian
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
LLC PiterClinica
City
Saint Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Facility Name
PEDIAMED s.r.o.
City
Bratislava
ZIP/Postal Code
831 03
Country
Slovakia
Facility Name
NASA DOKTORKA s.r.o.
City
Bratislava
ZIP/Postal Code
841 02
Country
Slovakia
Facility Name
Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.
City
Detva
ZIP/Postal Code
962 12
Country
Slovakia
Facility Name
MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast
City
Horne Srnie
ZIP/Postal Code
91442
Country
Slovakia
Facility Name
Všeobecná ambulancia pre deti a dorast
City
Humenne
ZIP/Postal Code
06601
Country
Slovakia
Facility Name
PEDAMB s.r.o.
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
MUDr. Drusková s.r.o.
City
Liptovská Osada
ZIP/Postal Code
034 73
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471012
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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