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

February 9, 2026 updated by: BioNTech SE

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guayama, Puerto Rico, 00784
        • Clinical Research Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center CTRU - 800 Welch Road
      • San Diego, California, United States, 92123
        • California Research Foundation
    • Florida
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Homestead, Florida, United States, 33030
        • C & R Research USA
      • Miami, Florida, United States, 33144
        • Bio-Medical Research LLC
      • Miami, Florida, United States, 33143
        • Florida Pharmaceutical Research and Associates
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • St. Petersburg, Florida, United States, 33705
        • GCP Research, Global Clinical professionals
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • AMR Clinical
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/ Adult Research
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Michigan Center of Medical Research (MICHMER)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Dayton, Ohio, United States, 45409
        • Dayton Clinical Research
      • South Euclid, Ohio, United States, 44121
        • Senders Pediatrics
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • Texas
      • Houston, Texas, United States, 77065
        • DM Clinical Research- Cyfair
      • Plano, Texas, United States, 75024
        • ACRC Trials
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • Stephenville, Texas, United States, 76401
        • Javara - Privia Medical Group North Texas - Stephenville
    • Utah
      • Layton, Utah, United States, 84041
        • AMR Clinical
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners, LLC
      • Richmond, Virginia, United States, 23233
        • Tekton Research, LLC.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-11 Years (Higher-Risk Individuals)
BNT162b2 (2025/2026 formulation)
Biological: BNT162b2 (2025/2026 formulation)
BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants reporting local reactions
Time Frame: For up to 7 days after vaccination
For up to 7 days after vaccination
Percentage of participants reporting systemic events
Time Frame: For up to 7 days after vaccination
For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time Frame: Through 1 month after vaccination
Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Time Frame: Through 6 months after vaccination
Through 6 months after vaccination
Geometric Mean Fold Rises (GMFRs)
Time Frame: From before vaccination to 1 month after vaccination
From before vaccination to 1 month after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNTech SE

Collaborators

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

October 28, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Actual)

October 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4591082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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