A Study to Learn About How a New Pneumococcal Vaccine Works in Children

Last updated: December 2, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Pneumococcal Disease

Treatment

20-valent pneumococcal conjugate vaccine (20vPnC)

PG4

Clinical Study ID

NCT06531538
C4931010
  • Ages 12-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andclinical judgment, to be eligible for the study.

  • Have received 3 infant doses of 20vPnC at 2, 4, and 6 months of age, with the lastdose administered >56 days before enrollment into the study. Documented confirmationof receipt will be collected prior to randomization.

Exclusion

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis).

  • Major known congenital malformation or serious chronic disorder.

  • Other acute or chronic medical or psychiatric condition or laboratory abnormalitythat may increase the risk associated with study participation or investigationalproduct administration or may interfere with the interpretation of study resultsand, in the judgment of the investigator, would make the participant inappropriatefor entry into this study.

  • Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: 20-valent pneumococcal conjugate vaccine (20vPnC)
Phase: 2
Study Start date:
July 30, 2024
Estimated Completion Date:
September 19, 2025

Connect with a study center

  • BRCR Medical Center - Ponce

    Ponce, 00717
    Puerto Rico

    Site Not Available

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • BRCR Global Puerto Rico

    San Juan, 00907
    Puerto Rico

    Site Not Available

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Bio-Medical Research LLC

    Miami, Florida 33144
    United States

    Site Not Available

  • Riveldi Biomedical Research and Associates - Miami Lakes

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Tekton Research, LLC.

    Chamblee, Georgia 30341
    United States

    Active - Recruiting

  • Javara - Privia Medical Group Georgia - Fayetteville

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Active - Recruiting

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Clinical Research Prime Rexburg

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • The Iowa Clinic

    Ankeny, Iowa 50023
    United States

    Active - Recruiting

  • All Children Pediatrics

    Louisville, Kentucky 40243
    United States

    Site Not Available

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Louisiana State University Health Sciences Shreveport - Fairfield avenue

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

  • Ochsner/LSU Health Ambulatory Care Center

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • University of Maryland, Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • The Pediatric Center

    Columbia, Maryland 21045
    United States

    Active - Recruiting

  • The Pediatric Center of Frederick

    Frederick, Maryland 21702
    United States

    Site Not Available

  • Child Health Care Associates

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Atrium Health - Strive Vaccine Research Clinic

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Atrium Health-Myers Park

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Duke Vaccine and Trials Unit

    Durham, North Carolina 27703
    United States

    Active - Recruiting

  • Durham Pediatrics at North Duke Street

    Durham, North Carolina 27704
    United States

    Active - Recruiting

  • Atrium Health-Matthews

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Senders Pediatrics

    South Euclid, Ohio 44121
    United States

    Active - Recruiting

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Active - Recruiting

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania 16506
    United States

    Site Not Available

  • Coastal Pediatric Research

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Active - Recruiting

  • Tekton Research, LLC.

    Beaumont, Texas 77706
    United States

    Active - Recruiting

  • Javara - Privia Medical Group North Texas - Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Oak Cliff Research Company, LLC

    Dallas, Texas 75252
    United States

    Active - Recruiting

  • PAS Research - McAllen

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • DM Clinical Research

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Kool Kids Pediatrics

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Mercury Clinical Research - Houston

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Pediatric Associates

    Houston, Texas 77087
    United States

    Active - Recruiting

  • Sunrise Pediatrics

    Houston, Texas 77077
    United States

    Active - Recruiting

  • University of Texas Medical Branch

    League City, Texas 77573
    United States

    Active - Recruiting

  • North Houston Internal Medicine & Pediatric Clinic

    Tomball, Texas 77375
    United States

    Site Not Available

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