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

Trial status:Will Be Recruiting
Trial ID:
C4591082
NCT ID:
NCT07222384
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Will Be Recruiting

Trial Details

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.

Medical Condition
  • COVID-19
    • Study Drug
  • BNT162b2 (2025/2026 formulation)
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    330
    Estimated Trial Date
    Oct 2025 - Oct 2026

    Trial Participant Requirements

    Age
    5 - 11 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    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.
    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.

    Trial Locations

    Location
    Status
    Location
    C & R Research USA
    Homestead, Florida, United States, 33030
    Status
    Location
    Florida Pharmaceutical Research and Associates
    Miami, Florida, United States, 33143
    Status
    Location
    J. Lewis Research, Inc. / Foothill Family Clinic
    Salt Lake City, Utah, United States, 84109
    Status
    Location
    J. Lewis Research, Inc. / Foothill Family Clinic South
    Salt Lake City, Utah, United States, 84121
    Status