A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
Public ClinicalTrials.gov record NCT07222384. 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 A BNT162b2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19
Study identification
- NCT ID
- NCT07222384
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 343 participants
Conditions and interventions
Conditions
Interventions
- BNT162b2 (2025/2026 formulation) Biological
Biological
Eligibility (public fields only)
- Age range
- 5 Years to 11 Years
- 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
- Oct 29, 2025
- Primary completion
- Jul 30, 2026
- Completion
- Jul 30, 2026
- Last update posted
- Feb 10, 2026
2025 – 2026
United States locations
- U.S. sites
- 27
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University Medical Center CTRU - 800 Welch Road | Palo Alto | California | 94304 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | — |
| C & R Research USA | Homestead | Florida | 33030 | — |
| Florida Pharmaceutical Research and Associates | Miami | Florida | 33143 | — |
| Bio-Medical Research LLC | Miami | Florida | 33144 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | 33705 | — |
| Medical Research Partners | Ammon | Idaho | 83406 | — |
| AMR Clinical | Oak Brook | Illinois | 60523 | — |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | — |
| Michigan Center of Medical Research (MICHMER) | Bingham Farms | Michigan | 48025 | — |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Dayton Clinical Research | Dayton | Ohio | 45409 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | — |
| ACRC Trials | Plano | Texas | 75024 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Javara - Privia Medical Group North Texas - Stephenville | Stephenville | Texas | 76401 | — |
| AMR Clinical | Layton | Utah | 84041 | — |
| 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 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | — |
| Tekton Research, LLC. | Richmond | Virginia | 23233 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07222384, 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 Feb 10, 2026 · Synced May 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07222384 live on ClinicalTrials.gov.