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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 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

NCT07069309

CompletedPhase 3

Sponsor: BioNTech SE

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

Interventions: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (19)
  • Walnut Creek, California, United States
  • Milford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Washington D.C., District of Columbia, United States
  • Hialeah, Florida, United States
  • Miami Lakes, Florida, United States
  • Honolulu, Hawaii, United States
  • Bardstown, Kentucky, United States
  • Springfield, Missouri, United States
  • Springfield, Missouri, United States
  • Rochester, New York, United States
  • Wilmington, North Carolina, United States
  • Cincinnati, Ohio, United States
  • South Euclid, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Salt Lake City, Utah, United States
  • Charlottesville, Virginia, United States