NCT07222384

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 (2025/2026 formulation)	BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-10-29
• Last updated: 2026-02-11

Locations

29 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study