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

NCT07222384 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: C4591082
• Study Type: interventional
• Target: 343
• Locations: 2 countries
• Sites: 29

Brief 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.

Conditions

COVID-19; SARS-COV-2 Infection

Keywords

Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Lung Diseases; Respiratory Tract Diseases; COVID-19; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines; Biological Products; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; BNT162 Vaccine

Outcome Measures

Primary Outcomes (5)

• Percentage of participants reporting local reactions

  For up to 7 days after vaccination

• Percentage of participants reporting systemic events

  For up to 7 days after vaccination

• Percentage of participants reporting adverse events

  Through 1 month after vaccination

• Percentage of participants reporting serious adverse events

  Through 6 months after vaccination

• Geometric Mean Fold Rises (GMFRs)

  From before vaccination to 1 month after vaccination

Study Arms (1)

5-11 Years (Higher-Risk Individuals)

EXPERIMENTAL

BNT162b2 (2025/2026 formulation)

Biological: BNT162b2 (2025/2026 formulation)

Interventions

BNT162b2 (2025/2026 formulation) BIOLOGICAL

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

5-11 Years (Higher-Risk Individuals)

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (29)

Stanford University Medical Center CTRU - 800 Welch Road

Palo Alto, California, 94304, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

C & R Research USA

Homestead, Florida, 33030, United States

Location

Florida Pharmaceutical Research and Associates

Miami, Florida, 33143, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States

Location

Medical Research Partners

Ammon, Idaho, 83406, United States

Location

AMR Clinical

Oak Brook, Illinois, 60523, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Michigan Center of Medical Research (MICHMER)

Bingham Farms, Michigan, 48025, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

DM Clinical Research- Cyfair

Houston, Texas, 77065, United States

Location

ACRC Trials

Plano, Texas, 75024, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Javara - Privia Medical Group North Texas - Stephenville

Stephenville, Texas, 76401, United States

Location

AMR Clinical

Layton, Utah, 84041, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Tekton Research, LLC.

Richmond, Virginia, 23233, United States

Location

Clinical Research Puerto Rico

Guayama, 00784, Puerto Rico

Location

Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Lung Diseases; Respiratory Tract Diseases

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 29, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); PR (2)