Condition: COVID-19 · SARS-COV-2 Infection · Sponsor: BioNTech SE
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 17 more locations — full list on the registry record.
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