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ACTIVE NOT RECRUITING 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

NCT07222384 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 343 participants
Start Date 2025-10-30
Est. Completion 2026-07-31
Phase Phase 3

Sponsor

BioNTech SE

123 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07222384

The ClinicalTrials.gov registry entry for NCT07222384 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07222384 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07222384?

The interventions under investigation include: BNT162b2 (2025/2026 formulation) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07222384?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial