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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2026-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 SARS-COV-2 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

This is an open-label study.

Study Groups

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5-11 Years (Higher-Risk Individuals)

BNT162b2 (2025/2026 formulation)

Group Type EXPERIMENTAL

BNT162b2 (2025/2026 formulation)

Intervention Type BIOLOGICAL

BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)

Interventions

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BNT162b2 (2025/2026 formulation)

BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes