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
Public ClinicalTrials.gov record NCT07069309. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07069309
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 774 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2025 (Actual)
- Primary completion
- May 1, 2026 (Actual)
- Completion
- May 1, 2026 (Actual)
- Last update posted
- Jun 1, 2026
2025 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Clinical Research Consulting | Milford | Connecticut | 06460 | — |
| GW Vaccine Research Unit | Washington D.C. | District of Columbia | 20037 | — |
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33014 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO | Springfield | Missouri | 65802 | — |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center | Springfield | Missouri | 65807 | — |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | — |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | — |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07069309, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07069309 live on ClinicalTrials.gov.