C4591082-Learn BNT162b2 (LP.8.1)–Adapted Vaccine Against SARS-CoV-2 in Children 5-11 Years Old
Research type
Research Study
Full title
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
IRAS ID
1013036
Contact name
Constantinos Katsoulas
Contact email
Sponsor organisation
Pfizer Inc.
Research 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 recommended SARS-CoV-2 strain).
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 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.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0312
Date of REC Opinion
3 Dec 2025
REC opinion
Further Information Unfavourable Opinion