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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
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.
Details
| Lead sponsor | BioNTech SE |
|---|---|
| Phase | PHASE3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 343 |
| Start date | Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Jul 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- COVID-19
- SARS-COV-2 Infection
Interventions
- BNT162b2 (2025/2026 formulation)
Countries
United States, Puerto Rico