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
NCT ID: NCT07069309
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
760 participants
INTERVENTIONAL
2025-07-08
2026-05-05
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: 18 through 64 years of age (higher-risk individuals)
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Group 2: 65 years of age and older
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Group 3: 12 through 64 years of age (higher-risk individuals)
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Group 4: 65 years of age and older
Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1
BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Interventions
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BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
DM Clinical Research- Cyfair
Houston, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4591076
Identifier Type: -
Identifier Source: org_study_id