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
Purpose
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.
Conditions
- COVID-19
- SARS-COV-2 Infection
Eligibility
- Eligible Ages
- Between 5 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- This is an open-label study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 5-11 Years (Higher-Risk Individuals) |
BNT162b2 (2025/2026 formulation) |
|
Recruiting Locations
More Details
- NCT ID
- NCT07222384
- Status
- Not yet recruiting
- Sponsor
- BioNTech SE