Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2026
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT06182124
Start Date
December 20 2023
End Date
May 23 2026
Last Update
October 14 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Alliance for Multispecialty Research, LLC
Doral, Florida, United States, 33172
2
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
3
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
4
Optimal Research
Peoria, Illinois, United States, 61614