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Study identifier: NCT07222384 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Completed

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

Condition: COVID-19 · SARS-COV-2 Infection  ·  Sponsor: BioNTech SE

PhasePhase 3
Planned participants344
Who can joinAll sexes, 5 Years to 11 Years
Healthy volunteersYesCheck eligibility criteria ↓
Where29 locations · 2 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Key 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. Key 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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (29)

Stanford University Medical Center CTRU - 800 Welch RoadPalo Alto, California, United States
California Research FoundationSan Diego, California, United States
C & R Research USAHomestead, Florida, United States
Florida Pharmaceutical Research and AssociatesMiami, Florida, United States
Bio-Medical Research LLCMiami, Florida, United States
Indago Research & Health Center, IncMiami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc.Orlando, Florida, United States
GCP Research, Global Clinical professionalsSt. Petersburg, Florida, United States
Medical Research PartnersAmmon, Idaho, United States
AMR ClinicalOak Brook, Illinois, United States
Kentucky Pediatric/ Adult ResearchBardstown, Kentucky, United States
Michigan Center of Medical Research (MICHMER)Bingham Farms, Michigan, United States

+ 17 more locations — full list on the registry record.

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