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OpenTrials
Completed

NCT Number: NCT06531538

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

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.

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Key information

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BRCR Medical Center - Ponce, Ponce, Puerto Rico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PG4

Biological

Multivalent pneumococcal conjugate vaccine.

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological

20-valent pneumococcal conjugate vaccine (20vPnC)

Other names: Prevnar 20

Primary outcomes

  1. Percentage of participants reporting prespecified local reactions within 7 days after each dose

    Time frame: 7 days after each dose

    Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose

  2. Percentage of participants reporting prespecified systemic events within 7 days after each dose

    Time frame: 7 days after each dose

    Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose

  3. Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination

    Time frame: From signing of ICD to 1 month after last assigned vaccination

    Adverse events occurring within 1 month after the last assigned vaccination

  4. Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination

    Time frame: From signing of ICD to 6 months after last assigned vaccination

    SAEs occurring from Dose 1 through 6 months after the last assigned vaccination

Secondary outcomes

  1. Pneumococcal serotype specific IgG concentrations

    Time frame: 1 month after last assigned vaccination

    Pneumococcal IgG GMCs 1 month after the last assigned vaccination

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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