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

Completed · Phase 3

Conditions studied: COVID-19, SARS-COV-2 Infection

In brief

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.

Key facts

Study ID

NCT07069309

Run by

BioNTech SE

People needed

774

Starts

2025-07-08

Expected to finish

2026-05-01

Last updated by the study team

2026-06-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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