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

Phase 1

Active, not recruiting

• Conditions: Pneumococcal Disease
• Interventions: Biological: Multivalent Pneumococcal Vaccine - Formulation 1; Biological: Multivalent Pneumococcal Vaccine - Formulation 2; Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); Biological: Licensed pneumococcal comparator vaccine; Biological: Multivalent Pneumococcal Vaccine - Formulation 3; Biological: Multivalent Pneumococcal Vaccine - Formulation 4

• Registration Number: NCT06182124
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-08
• Study Start: 2023-12-20
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2023-12-26
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-09
• Last Update Posted: 2025-10-14
• Primary Completion: 2026-05-23
• Study Completion: 2026-05-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

• Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent
• Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
• Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
• Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
• Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced)

Exclusion Criteria

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
• Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
• Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
• Known or suspected immunodeficiency or other conditions associated with immunosuppression
• Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
• Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1	Multivalent Pneumococcal Vaccine - Formulation 1	Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2	Multivalent Pneumococcal Vaccine - Formulation 2	Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).
Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)	20-valent pneumococcal conjugate vaccine (20vPnC)	Participants to receive a single injection of 20vPnC.
Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine	Licensed pneumococcal comparator vaccine	Participants to receive a single injection of a licensed pneumococcal comparator vaccine.
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3	Multivalent Pneumococcal Vaccine - Formulation 3	Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3.
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4	Multivalent Pneumococcal Vaccine - Formulation 4	Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4.

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination	1 month	Adverse events occurring within 1 month after vaccination
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination	6 months	SAEs occurring within 6 months after vaccination
Percentage of participants reporting prespecified systemic events within 7 days after vaccination	7 days	Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
Percentage of participants reporting prespecified local reactions within 7 days after vaccination	7 days	Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination	12 months	Related SAEs occurring through 12 months after vaccination

Secondary Outcome Measures

Name	Time	Method
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)	1 month after vaccination	Pneumococcal OPA GMTs 1 month after vaccination

Trial Locations

Locations (15)

AMR Clinical; 🇺🇸 Knoxville, Tennessee, United States

DM Clinical Research; 🇺🇸 Tomball, Texas, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 New Orleans, Louisiana, United States

Indago Research & Health Center, Inc; 🇺🇸 Hialeah, Florida, United States

Clinical Research Atlanta; 🇺🇸 Stockbridge, Georgia, United States

Optimal Research; 🇺🇸 Peoria, Illinois, United States

Headlands Research - Detroit; 🇺🇸 Southfield, Michigan, United States

Rochester Clinical Research, LLC; 🇺🇸 Rochester, New York, United States

Accellacare - Wilmington; 🇺🇸 Wilmington, North Carolina, United States

Headlands Horizons LLC; 🇺🇸 Brownsville, Texas, United States

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