A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults

Summary

The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.

This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.

Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.

Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.

Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.

Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.

Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.

Conditions

• Pneumococcal Disease

Interventions

BIOLOGICAL

Multivalent Pneumococcal Vaccine - Formulation 1

Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).

BIOLOGICAL

Multivalent Pneumococcal Vaccine - Formulation 2

Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).

BIOLOGICAL

20-valent pneumococcal conjugate vaccine (20vPnC)

20-valent pneumococcal conjugate vaccine (20vPnC)

BIOLOGICAL

Licensed pneumococcal comparator vaccine

A licensed pneumococcal comparator vaccine

BIOLOGICAL

Multivalent Pneumococcal Vaccine - Formulation 3

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL

Multivalent Pneumococcal Vaccine - Formulation 4

Multivalent pneumococcal conjugate vaccine

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-20

Primary Completion

2026-05-23

Completion

2026-05-23

FDA Drug

Yes

Countries

• United States

Study Locations