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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162b2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR SEVERE COVID-19

NCT07222384•BioNTech SE

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

5 - 11 years

Sex

ALL

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.

Locations (29)

Stanford University Medical Center CTRU - 800 Welch Road

Palo Alto, California, United States

California Research Foundation

San Diego, California, United States

Indago Research & Health Center, Inc

Hialeah, Florida, 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

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

Key Dates

Start Date

October 30, 2025

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

February 11, 2026

Enrollment

343

ACTUAL participants

Conditions

COVID-19SARS-COV-2 Infection

Interventions

BNT162b2 (2025/2026 formulation)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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