NCT07069309

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• SARS-COV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)	BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)

Timeline

• Start date: 2025-07-08
• Primary completion: 2026-05-05
• Completion: 2026-05-05
• First posted: 2025-07-16
• Last updated: 2025-12-22

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study