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

Completed · Phase 2

Conditions studied: Pneumococcal Disease

In brief

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.

Key facts

Study ID

NCT06531538

Run by

Pfizer

People needed

225

Starts

2024-07-30

Expected to finish

2026-02-09

Last updated by the study team

2026-03-11

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
• Bio-Medical Research LLC — Miami, Florida, United States
• Tekton Research, LLC. — Chamblee, Georgia, United States
• Javara - Privia Medical Group Georgia - Fayetteville — Fayetteville, Georgia, United States
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
• The Iowa Clinic — Ankeny, Iowa, United States
• Louisiana State University Health Sciences Shreveport - Fairfield avenue — Shreveport, Louisiana, United States
• Louisiana State University Health Sciences Shreveport — Shreveport, Louisiana, United States
• Ochsner/LSU Health Ambulatory Care Center — Shreveport, Louisiana, United States
• University of Maryland, Baltimore - Institutional Review Board — Baltimore, Maryland, United States
• University of Maryland, Baltimore, Center for Vaccine Development and Global Health — Baltimore, Maryland, United States
• The Pediatric Center — Columbia, Maryland, United States
• Atrium Health - Strive Vaccine Research Clinic — Charlotte, North Carolina, United States
• Atrium Health-Myers Park — Charlotte, North Carolina, United States
• Duke Vaccine and Trials Unit — Durham, North Carolina, United States
• Durham Pediatrics at North Duke Street — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Atrium Health-Matthews — Matthews, North Carolina, United States
• Senders Pediatrics — South Euclid, Ohio, United States
• Carolina Family Care — Charleston, South Carolina, United States
• MUSC Children's Health — Charleston, South Carolina, United States
• Carolina Family Care — Summerville, South Carolina, United States
• MUSC Children's Health — Summerville, South Carolina, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Pediatric Clinical Trials of Tennessee, LLC — Tullahoma, Tennessee, United States

Full record on ClinicalTrials.gov

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