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

Phase 2

Active, not recruiting

• Conditions: Pneumococcal Disease
• Interventions: Biological: PG4; Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

• Registration Number: NCT06531538
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-29
• Study Start: 2024-07-30
• Study First Posted: 2024-08-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-02-16
• Study Completion: 2026-02-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG4 2-Dose Group	PG4	Participants to receive two injections of Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)	20-valent pneumococcal conjugate vaccine (20vPnC)	Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).
PG4 1-Dose Group	PG4	Participants to receive a single injection of Multivalent Pneumococcal Vaccine

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting prespecified local reactions within 7 days after each dose	7 days after each dose	Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination	From signing of ICD to 1 month after last assigned vaccination	Adverse events occurring within 1 month after the last assigned vaccination
Percentage of participants reporting prespecified systemic events within 7 days after each dose	7 days after each dose	Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination	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 Outcome Measures

Name	Time	Method
Pneumococcal serotype specific IgG concentrations	1 month after last assigned vaccination	Pneumococcal IgG GMCs 1 month after the last assigned vaccination

Trial Locations

Locations (45)

Emerson Clinical Research Institute; 🇺🇸 Washington, District of Columbia, United States

Riveldi Biomedical Research and Associates - Miami Lakes; 🇺🇸 Miami Lakes, Florida, 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

Clinical Research Prime; 🇺🇸 Idaho Falls, Idaho, United States

Clinical Research Prime Rexburg; 🇺🇸 Rexburg, Idaho, United States

The Iowa Clinic; 🇺🇸 Ankeny, Iowa, United States

All Children Pediatrics; 🇺🇸 Louisville, Kentucky, United States

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