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NCT07069309 · ClinicalTrials.gov registry record · Phase 3
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 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 3
- Development phase
- 760
- Enrollment target
- 19
- Study locations
NCT07069309: Active Phase 3 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.
NCT07069309 is a Phase 3 study of COVID-19 and SARS CoV 2 Infection that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 760 participants, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07069309, a Phase 3 study of COVID-19 and SARS CoV 2 Infection, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 760 participants
- Enrollment target
- 19
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
Study Locations (19)
District of Columbia
- GW Vaccine Research Unit - Washington D.C.
- The GW Medical Faculty Associates - Washington D.C.
Florida
- Indago Research & Health Center, Inc - Hialeah
- Palm Springs Community Health Center - Miami Lakes
Missouri
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO - Springfield
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center - Springfield
Ohio
- CTI Clinical Research Center - Cincinnati
- Senders Pediatrics - South Euclid
Utah
- J. Lewis Research, Inc. / Foothill Family Clinic - Salt Lake City
- J. Lewis Research, Inc. / Foothill Family Clinic South - Salt Lake City
California
- Diablo Clinical Research, Inc. - Walnut Creek
Connecticut
- Clinical Research Consulting - Milford
Hawaii
- East-West Medical Research Institute - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 760 participants |
| Start Date | 2025-07-08 |
| Est. Completion | 2026-05-05 |
| Phase | Phase 3 |
What the registry record for NCT07069309 still lists
NCT07069309 is an interventional study that assigns participants to a tested intervention. The registered 760 participants enrollment target is mid-sized for trials with a published cap, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) is the first listed.
NCT07069309 lists 19 locations in 14 states (District of Columbia, Florida, Missouri).
Frequently Asked Questions
What is clinical trial NCT07069309 about?
NCT07069309 is a clinical study titled "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". 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...
What is the current status of trial NCT07069309?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 760 participants. The study started on 2025-07-08. Estimated completion is 2026-05-05.
What conditions does trial NCT07069309 study?
This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection.
What interventions are being tested in trial NCT07069309?
The interventions under investigation include: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07069309?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07069309 being conducted?
This trial has 19 study locations across California, Connecticut, District of Columbia, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07069309's enrollment target sits among peer trials
760 91st of 298 higher than 208 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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