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NCT07222384 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
- 20
- Study locations
NCT07222384: Active Phase 3 study of COVID-19 and SARS CoV 2 Infection, sponsored by BioNTech SE.
NCT07222384 is a Phase 3 study of COVID-19 and SARS CoV 2 Infection that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 343 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07222384, a Phase 3 study of COVID-19 and SARS CoV 2 Infection, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
- 20
- Study locations
Study 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 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 Studied
Interventions
- BIOLOGICAL BNT162b2 (2025/2026 formulation)
Study Locations (20)
Florida
- Indago Research & Health Center, Inc - Hialeah
- C & R Research USA - Homestead
- Florida Pharmaceutical Research and Associates - Miami
- Bio-Medical Research LLC - Miami
- Clinical Neuroscience Solutions, Inc. - Orlando
- GCP Research, Global Clinical professionals - St. Petersburg
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Dayton Clinical Research - Dayton
- Senders Pediatrics - South Euclid
California
- Stanford University Medical Center CTRU - 800 Welch Road - Palo Alto
- California Research Foundation - San Diego
Texas
- DM Clinical Research- Cyfair - Houston
- ACRC Trials - Plano
Idaho
- Medical Research Partners - Ammon
Illinois
- AMR Clinical - Oak Brook
Kentucky
- Kentucky Pediatric/ Adult Research - Bardstown
Michigan
- Michigan Center of Medical Research (MICHMER) - Bingham Farms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2025-10-30 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 3 |
What the registry record for NCT07222384 still lists
NCT07222384 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which BNT162b2 (2025/2026 formulation) is the first listed.
NCT07222384 names 20 study sites across 11 states, led by Florida, Ohio, California.
Frequently Asked Questions
What is clinical trial NCT07222384 about?
NCT07222384 is a clinical study titled "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". 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 ...
What is the current status of trial NCT07222384?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2025-10-30. Estimated completion is 2026-07-31.
What conditions does trial NCT07222384 study?
This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection.
What interventions are being tested in trial NCT07222384?
The interventions under investigation include: BNT162b2 (2025/2026 formulation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07222384?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07222384 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07222384's enrollment target sits among peer trials
343 134th of 298 higher than 165 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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