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
Completed · Phase 3
Conditions studied: COVID-19, SARS-COV-2 Infection
In brief
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.
Key facts
- Study ID
- NCT07222384
- Run by
- BioNTech SE
- People needed
- 344
- Starts
- 2025-10-30
- Expected to finish
- 2026-07-24
- Last updated by the study team
- 2026-08-07
Who can join
Age: 5 and older, up to 11. Sex: any. Healthy volunteers: accepted.
Where it is running
- Stanford University Medical Center CTRU - 800 Welch Road — Palo Alto, California, United States
- California Research Foundation — San Diego, California, United States
- C & R Research USA — Homestead, Florida, United States
- Florida Pharmaceutical Research and Associates — Miami, Florida, United States
- Bio-Medical Research LLC — Miami, Florida, United States
- Indago Research & Health Center, Inc — Miami Lakes, Florida, United States
- Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
- GCP Research, Global Clinical professionals — St. Petersburg, Florida, United States
- Medical Research Partners — Ammon, Idaho, United States
- AMR Clinical — Oak Brook, Illinois, United States
- Kentucky Pediatric/ Adult Research — Bardstown, Kentucky, United States
- Michigan Center of Medical Research (MICHMER) — Bingham Farms, Michigan, United States
- Clinical Research Institute — Minneapolis, Minnesota, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Cincinnati Children's Hospital Medical Center- Infectious Disease — Cincinnati, Ohio, United States
- Dayton Clinical Research — Dayton, Ohio, United States
- Senders Pediatrics — South Euclid, Ohio, United States
- Coastal Carolina Research Center — North Charleston, South Carolina, United States
- DM Clinical Research- Cyfair — Houston, Texas, United States
- ACRC Trials — Plano, Texas, United States
- Sun Research Institute — San Antonio, Texas, United States
- Javara - Privia Medical Group North Texas - Stephenville — Stephenville, Texas, United States
- AMR Clinical — Layton, Utah, United States
- J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
- J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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