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

BioNTech

Status and phase

Not yet enrolling

Phase 3

Conditions

COVID-19

SARS-COV-2 Infection

Treatments

Biological: BNT162b2 (2025/2026 formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07222384

C4591082

Details and patient eligibility

About

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.

Enrollment

330 estimated patients

Sex

All

Ages

5 to 11 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.