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

Not Applicable

Not yet recruiting

• Conditions: COVID-19; SARS-COV-2 Infection
• Interventions: Biological: BNT162b2 (2025/2026 formulation)

• Registration Number: NCT07222384
• Lead Sponsor: BioNTech SE

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-28
• Study First Submitted QC: 2025-10-28
• Last Update Submitted: 2025-10-28
• Study First Posted: 2025-10-29
• Last Update Posted: 2025-10-29
• Study Start: 2025-10-30
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5-11 Years (Higher-Risk Individuals)	BNT162b2 (2025/2026 formulation)	BNT162b2 (2025/2026 formulation)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

C & R Research USA; 🇺🇸 Homestead, Florida, United States

Florida Pharmaceutical Research and Associates; 🇺🇸 Miami, Florida, United States

J. Lewis Research, Inc. / Foothill Family Clinic; 🇺🇸 Salt Lake City, Utah, United States

J. Lewis Research, Inc. / Foothill Family Clinic South; 🇺🇸 Salt Lake City, Utah, United States