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

Completed · Phase 1/Phase 2

Conditions studied: Pneumococcal Disease

In brief

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.

Key facts

Study ID

NCT06182124

Run by

Pfizer

People needed

1363

Starts

2023-12-20

Expected to finish

2026-05-12

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Alliance for Multispecialty Research, LLC — Doral, Florida, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Optimal Research — Peoria, Illinois, United States
• Alliance for Multispecialty Research, LLC — New Orleans, Louisiana, United States
• Headlands Research - Detroit — Southfield, Michigan, United States
• Rochester Clinical Research, LLC — Rochester, New York, United States
• IMA Evaluations, LLC dba IMA Clinical Research — Tarrytown, New York, United States
• Accellacare - Wilmington — Wilmington, North Carolina, United States
• AMR Clinical — Knoxville, Tennessee, United States
• AMR Clinical — Knoxville, Tennessee, United States
• Headlands Horizons LLC — Brownsville, Texas, United States
• DM Clinical Research- Cyfair — Houston, Texas, United States
• Clinical Trials of Texas, LLC dba Flourish Research — San Antonio, Texas, United States
• IMA Clinical Research San Antonio — San Antonio, Texas, United States
• Dynamed Clinical Research, LP d/b/a DM Clinical Research — Sugar Land, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• Dynamed Clinical Research, LP d/b/a DM Clinical Research — Tomball, Texas, United States
• J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
• J. Lewis Research, Inc. — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.