A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: Multivalent Pneumococcal Vaccine - Formulation 1Biological: Multivalent Pneumococcal Vaccine - Formulation 2Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)Biological: Licensed pneumococcal comparator vaccine
- 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 3 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.
Participants will take part in this study for about 6 months for Stage 1 and Stage 3, 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 418
- Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2 and Stage 3) 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 (Stage 2): 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)
- Phase 2 (Stage 3): 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)
- 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) and Phase 2(Stage 3). 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) and Phase 2(Stage 3). 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.
- 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 (14)
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, 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
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 - MDC
🇺🇸Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States