A Study to Learn About How a New Pneumococcal Vaccine Works in Children
A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
2 other identifiers
interventional
225
2 countries
39
Brief Summary
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2026
CompletedMarch 11, 2026
March 1, 2026
1.5 years
July 23, 2024
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of participants reporting prespecified local reactions within 7 days after each dose
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
7 days after each dose
Percentage of participants reporting prespecified systemic events within 7 days after each dose
Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
7 days after each dose
Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination
Adverse events occurring within 1 month after the last assigned vaccination
From signing of ICD to 1 month after last assigned vaccination
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
From signing of ICD to 6 months after last assigned vaccination
Secondary Outcomes (1)
Pneumococcal serotype specific IgG concentrations
1 month after last assigned vaccination
Study Arms (3)
PG4 1-Dose Group
EXPERIMENTALParticipants to receive a single injection of Multivalent Pneumococcal Vaccine
PG4 2-Dose Group
EXPERIMENTALParticipants to receive two injections of Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
ACTIVE COMPARATORParticipants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).
Interventions
20-valent pneumococcal conjugate vaccine (20vPnC)
Eligibility Criteria
You may qualify if:
- Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- Have received 3 infant doses of 20vPnC with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
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 (other than 20vPnC) or planned receipt during study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (39)
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009, United States
Bio-Medical Research LLC
Miami, Florida, 33144, United States
Tekton Research, LLC.
Chamblee, Georgia, 30341, United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, 30214, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
The Iowa Clinic
Ankeny, Iowa, 50023, United States
Louisiana State University Health Sciences Shreveport - Fairfield avenue
Shreveport, Louisiana, 71101, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103, United States
Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, 71103, United States
University of Maryland, Baltimore - Institutional Review Board
Baltimore, Maryland, 21201, United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201, United States
The Pediatric Center
Columbia, Maryland, 21045, United States
Atrium Health - Strive Vaccine Research Clinic
Charlotte, North Carolina, 28207, United States
Atrium Health-Myers Park
Charlotte, North Carolina, 28207, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, 27704, United States
Duke University
Durham, North Carolina, 27705, United States
Atrium Health-Matthews
Matthews, North Carolina, 28105, United States
Senders Pediatrics
South Euclid, Ohio, 44121, United States
Carolina Family Care
Charleston, South Carolina, 29414, United States
MUSC Children's Health
Charleston, South Carolina, 29414, United States
Carolina Family Care
Summerville, South Carolina, 29486, United States
MUSC Children's Health
Summerville, South Carolina, 29486, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, Tennessee, 37388, United States
Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, 75230, United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75252, United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75287, United States
Mercury Clinical Research - Houston
Houston, Texas, 77054, United States
DM Clinical Research - Kool Kids Pediatrics
Houston, Texas, 77065, United States
Kool Kids Pediatrics
Houston, Texas, 77065, United States
Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, 77077, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087, United States
University of Texas Medical Branch
League City, Texas, 77573, United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, 77375, United States
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
BRCR Medical Center - Ponce
Ponce, 00717, Puerto Rico
BRCR Global Puerto Rico
San Juan, 00907-1509, Puerto Rico
CMRC Headlands, LLC
San Juan, 00918, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Study is partially blinded as 2 of the 3 groups are blinded and 1 is unblinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2024
First Posted
August 1, 2024
Study Start
July 30, 2024
Primary Completion
February 9, 2026
Study Completion
February 9, 2026
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.