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
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, called BNT162b2 (2025/2026 formulation). This study is seeking participants 5 through 11 years of age who: * have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19, * and are medically stable. All participants in this study will receive 1 vaccine dose given in the muscle of their arm of a BNT162b2 (2025/2026 formulation) vaccine which targets the COVID-19 virus, specifically the strain selected for the 2025-2026 COVID-19 viral respiratory season. Participants will take part in this study for about 6 months and will need to visit the clinical study site at least 2 times.
Study identification
- NCT ID
- NCT07222384
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 344 participants
Conditions and interventions
Conditions
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 30, 2025 (Actual)
- Primary completion
- Jul 24, 2026 (Actual)
- Completion
- Jul 24, 2026 (Actual)
- Last update posted
- Aug 7, 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 | — |
| C & R Research USA | Homestead | Florida | 33030 | — |
| Florida Pharmaceutical Research and Associates | Miami | Florida | 33143 | — |
| Bio-Medical Research LLC | Miami | Florida | 33144 | — |
| Indago Research & Health Center, Inc | Miami Lakes | Florida | 33016 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | 33714 | — |
| 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- Infectious Disease | Cincinnati | Ohio | 45206 | — |
| 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 Aug 7, 2026 · Synced Oct 30, 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 public registry record, listed eligibility criteria, and available contact information for NCT07222384 live on ClinicalTrials.gov.