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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); Biological: PG4

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc.
  • Ponce, Puerto Rico, 00717
    • BRCR Medical Center - Ponce
  • San Juan, Puerto Rico, 00907-1509
    • BRCR Global Puerto Rico
  • San Juan, Puerto Rico, 00918
    • CMRC Headlands, LLC
• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20009
      • Emerson Clinical Research Institute
  • Florida
    • Miami, Florida, United States, 33144
      • Bio-Medical Research LLC
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Tekton Research, LLC.
    • Fayetteville, Georgia, United States, 30214
      • Javara - Privia Medical Group Georgia - Fayetteville
    • Union City, Georgia, United States, 30291
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • The Iowa Clinic
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Shreveport
    • Shreveport, Louisiana, United States, 71101
      • Louisiana State University Health Sciences Shreveport - Fairfield avenue
    • Shreveport, Louisiana, United States, 71103
      • Ochsner/LSU Health Ambulatory Care Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore, Center for Vaccine Development and Global Health
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore - Institutional Review Board
    • Columbia, Maryland, United States, 21045
      • The Pediatric Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health - Strive Vaccine Research Clinic
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health-Myers Park
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Durham, North Carolina, United States, 27703
      • Duke Vaccine and Trials Unit
    • Durham, North Carolina, United States, 27704
      • Durham Pediatrics at North Duke Street
    • Matthews, North Carolina, United States, 28105
      • Atrium Health-Matthews
  • Ohio
    • South Euclid, Ohio, United States, 44121
      • Senders Pediatrics
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Carolina Family Care
    • Charleston, South Carolina, United States, 29414
      • MUSC Children's Health
    • Summerville, South Carolina, United States, 29486
      • Carolina Family Care
    • Summerville, South Carolina, United States, 29486
      • MUSC Children's Health
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Tullahoma, Tennessee, United States, 37388
      • Pediatric Clinical Trials of Tennessee, LLC
  • Texas
    • Dallas, Texas, United States, 75252
      • Oak Cliff Research Company, LLC
    • Dallas, Texas, United States, 75287
      • Oak Cliff Research Company, LLC
    • Dallas, Texas, United States, 75230
      • Javara - Privia Medical Group North Texas - Dallas
    • Houston, Texas, United States, 77065
      • Kool Kids Pediatrics
    • Houston, Texas, United States, 77054
      • Mercury Clinical Research - Houston
    • Houston, Texas, United States, 77077
      • Mercury Clinical Research - Sunrise Pediatrics
    • Houston, Texas, United States, 77087
      • Mercury Clinical Research - Pediatric Associates
    • Houston, Texas, United States, 77065
      • DM Clinical Research - Kool Kids Pediatrics
    • League City, Texas, United States, 77573
      • University of Texas Medical Branch
    • Tomball, Texas, United States, 77375
      • Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

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 (other than 20vPnC) or planned receipt during study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PG4 1-Dose Group; Participants to receive a single injection of Multivalent Pneumococcal Vaccine	Biological: PG4; Multivalent pneumococcal conjugate vaccine.
Experimental: PG4 2-Dose Group; Participants to receive two injections of Multivalent Pneumococcal Vaccine	Biological: PG4; Multivalent pneumococcal conjugate vaccine.
Active Comparator: 20-valent pneumococcal conjugate vaccine (20vPnC); Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).	Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); 20-valent pneumococcal conjugate vaccine (20vPnC); Other Names: Prevnar 20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal serotype specific IgG concentrations	Pneumococcal IgG GMCs 1 month after the last assigned vaccination	1 month after last assigned vaccination

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): February 9, 2026
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: C4931010; C4931010-OPENLABEL (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No