Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

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

Lead Sponsor:

BioNTech SE

Collaborating Sponsors:

Pfizer

Conditions:

COVID-19

SARS-COV-2 Infection

Eligibility:

All Genders

5-11 years

Phase:

PHASE3

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 partici...

Eligibility Criteria

Inclusion

  • Key
  • 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

  • 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.

Key Trial Info

Start Date :

October 30 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 30 2026

Estimated Enrollment :

330 Patients enrolled

Trial Details

Trial ID

NCT07222384

Start Date

October 30 2025

End Date

October 30 2026

Last Update

December 3 2025

Active Locations (28)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 7 (28 locations)

1

California Research Foundation

San Diego, California, United States, 92123

2

Stamford Therapeutics Consortium

Stamford, Connecticut, United States, 06905

3

Indago Research & Health Center, Inc

Hialeah, Florida, United States, 33012

4

C & R Research USA

Homestead, Florida, United States, 33030