A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
A Phase 3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants 12 Through 64 Years of Age Considered at Higher Risk of Severe COVID-19, and Participants ≥65 Years of Age
1 other identifier
interventional
760
1 country
19
Brief Summary
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19. This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Jul 2025
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2025
CompletedStudy Start
First participant enrolled
July 8, 2025
CompletedFirst Posted
Study publicly available on registry
July 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2026
CompletedDecember 22, 2025
December 1, 2025
10 months
July 7, 2025
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
Percentage of participants reporting local reactions
For up to 7 days after vaccination
Percentage of participants reporting systemic events
For up to 7 days after vaccination
Percentage of participants reporting adverse events
Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Through 6 months after vaccination
Cohort 1: Geometric Mean Titers (GMTs)
At 2 weeks after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
From before vaccination to 2 weeks after vaccination
Cohort 1: Percentages of participants with seroresponse
2 weeks after vaccination
Cohort 2: Geometric Mean Fold Rises (GMFRs)
From before vaccination to 1 month after vaccination
Secondary Outcomes (5)
Cohort 1: Geometric Mean Titers (GMTs)
At 1 month after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
From before vaccination to 1 month after vaccination
Cohort 1: Percentages of participants with seroresponse
1 month after vaccination
Cohort 2: Geometric Mean Titers (GMTs)
From before vaccination to 1 month after vaccination
Cohort 2: Percentages of participants with seroresponse
1 month after vaccination
Study Arms (4)
Group 1: 18 through 64 years of age (higher-risk individuals)
EXPERIMENTALParticipants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Group 2: 65 years of age and older
EXPERIMENTALParticipants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Group 3: 12 through 64 years of age (higher-risk individuals)
EXPERIMENTALParticipants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Group 4: 65 years of age and older
EXPERIMENTALParticipants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
Interventions
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Eligibility Criteria
You may qualify if:
- Cohort 1: Participants 18 years of age or older.
- Cohort 2: Participants 12 years of age or older.
- Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19.
You may not qualify if:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- History of myocarditis or pericarditis.
- Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 5 months (150 days) prior to study enrollment.
- Refer to the study contact for further eligibility details.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Pfizercollaborator
Study Sites (19)
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, 20037, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, 65807, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Senders Pediatrics
South Euclid, Ohio, 44121, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
DM Clinical Research- Cyfair
Houston, Texas, 77065, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2025
First Posted
July 16, 2025
Study Start
July 8, 2025
Primary Completion
May 5, 2026
Study Completion
May 5, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share