NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: BioNTech SE
Conditions: COVID-19, SARS-COV-2 Infection
Interventions: BNT162b2 (2025/2026 formulation)
Countries: United States, Puerto Rico
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.
Sex: ALL
Age: 5 Years to 11 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Key Inclusion Criteria: * Children 5 through 11 years of age at their first appointment. * Children with at least 1 underlying stable medical condition that increases their risk of severe COVID-19, as listed in the protocol. Key Exclusion Criteria: * Children who have had confirmed COVID-19 within the last 5 months (150 days). * Children who have received a COVID-19 vaccine, either as part of a research study or an approved vaccine, within the last 5 months (150 days). * Children who have received a 2025-2026 seasonal COVID-19 vaccination. * Children with a history of myocarditis or pericarditis. * Children with a previous or current diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) * Children with a medical condition wherein they would be considered for a second dose of COVID-19 vaccine to protect against risk of severe COVID-19 based on standard of care. Refer to the study contact for further eligibility details.
- Palo Alto, California, United States
- San Diego, California, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Ammon, Idaho, United States
- Oak Brook, Illinois, United States
- Bardstown, Kentucky, United States
- Bingham Farms, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, New York, United States
- Cincinnati, Ohio, United States
- Dayton, Ohio, United States
- South Euclid, Ohio, United States
- North Charleston, South Carolina, United States
- Houston, Texas, United States
- Plano, Texas, United States
- San Antonio, Texas, United States
- Stephenville, Texas, United States
- Layton, Utah, United States
- Salt Lake City, Utah, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, United States
- Richmond, Virginia, United States
- Guayama, Puerto RICO, Puerto Rico
- Ponce, Puerto RICO, Puerto Rico