A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
NCT06182124
Phase
Phase 1/Phase 2
Recruitment status
Completed
Participants
1,363
Lead sponsor
Pfizer
Start date
2023-12-20
Number of sites
- 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.
- Short title
- A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2026-05-12
- First posted
- 2023-12-26
- Registry last updated
- 2026-06-10
- Primary completion date
- 2026-05-12
- Start date
- 2023-12-20
- Actual participants
- 1,363
- Participants
- 1,363
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pfizer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06182124
- ClinicalTrials.gov ID
- NCT06182124
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Sources for study design
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Timeframe: 7 days
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Percentage of participants reporting prespecified systemic events within 7 days after vaccination
Timeframe: 7 days
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Timeframe: 1 month
Adverse events occurring within 1 month after vaccination
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
Timeframe: 6 months
SAEs occurring within 6 months after vaccination
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
Timeframe: 12 months
Related SAEs occurring through 12 months after vaccination
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Timeframe: 1 month after vaccination
Pneumococcal OPA GMTs 1 month after vaccination
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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)
- 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
Sources for eligibility
- Alliance for Multispecialty Research, LLCDoral, United States
- Indago Research & Health Center, IncHialeah, United States
- Clinical Research AtlantaStockbridge, United States
- Optimal ResearchPeoria, United States
- Alliance for Multispecialty Research, LLCNew Orleans, United States
- Headlands Research - DetroitSouthfield, United States
- Rochester Clinical Research, LLCRochester, United States
- IMA Evaluations, LLC dba IMA Clinical ResearchTarrytown, United States
- Accellacare - WilmingtonWilmington, United States
- AMR ClinicalKnoxville, United States
- AMR ClinicalKnoxville, United States
- Headlands Horizons LLCBrownsville, United States
- DM Clinical Research- CyfairHouston, United States
- Clinical Trials of Texas, LLC dba Flourish ResearchSan Antonio, United States
- IMA Clinical Research San AntonioSan Antonio, United States
- Dynamed Clinical Research, LP d/b/a DM Clinical ResearchSugar Land, United States
- DM Clinical ResearchTomball, United States
- Dynamed Clinical Research, LP d/b/a DM Clinical ResearchTomball, United States
- J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake City, United States
- J. Lewis Research, Inc.Salt Lake City, United States
Sources for sites
- Related resource (pmiform.com)
Other registry identifiers
- NCT06182124
Sources for references
Related records
Drugs (4)
- Artesunate
- Clofarabine
- Insulin efsitora alfa
- Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197