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

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Pneumococcal Disease

Treatments: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); Biological: PG4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06531538

C4931010

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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 at 2, 4, and 6 months of age, 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups

PG4 1-Dose Group

Experimental group

Description:

Participants to receive a single injection of Multivalent Pneumococcal Vaccine

Treatment:

Biological: PG4

PG4 2-Dose Group

Experimental group

Description:

Participants to receive two injections of Multivalent Pneumococcal Vaccine

Treatment:

Biological: PG4

20-valent pneumococcal conjugate vaccine (20vPnC)

Active Comparator group

Description:

Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)