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Purpose

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

Eligibility

Eligible Ages
Between 5 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
This is an open-label study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
5-11 Years (Higher-Risk Individuals) 		BNT162b2 (2025/2026 formulation)
  • Biological: BNT162b2 (2025/2026 formulation)
    BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)

Recruiting Locations

More Details

NCT ID
NCT07222384
Status
Not yet recruiting
Sponsor
BioNTech SE

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.