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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
Sponsor: BioNTech SE
Summary
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.
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
Key Details
Gender
All
Age Range
5 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
343
Start Date
2025-10-30
Completion Date
2026-07-31
Last Updated
2026-02-11
Healthy Volunteers
Yes
Conditions
Interventions
BNT162b2 (2025/2026 formulation)
BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)
Locations (29)
Stanford University Medical Center CTRU - 800 Welch Road
Palo Alto, California, United States
California Research Foundation
San Diego, California, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 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
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
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
Clinical Research Partners, LLC
Richmond, Virginia, United States
Tekton Research, LLC.
Richmond, Virginia, United States
Clinical Research Puerto Rico
Guayama, Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, Puerto Rico