NCT06182124

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

A Phase 1/2, Randomized, Double-Blind Trial of the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-05-23
• Completion: 2026-05-23
• First posted: 2023-12-26
• Last updated: 2025-10-14

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study