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New COVID shot tested in vulnerable kids

NCT ID NCT07222384

Vaccine Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This Phase 3 trial tests an updated COVID-19 vaccine (BNT162b2, 2025/2026 formulation) in 343 children aged 5 to 11 who have medical conditions that put them at high risk for severe COVID-19. All participants receive one dose and are monitored for about 6 months to check safety and immune response. The goal is to see if the updated vaccine is safe and works well in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BNT162b2 (2025/2026 formulation) COVID-19 vaccine
What this could lead to
If successful, this could show that an updated COVID-19 vaccine is safe and effective for high-risk children, helping protect them from severe illness.
What could go wrong
This is a relatively small Phase 3 trial (343 participants) and focuses on immune response and safety, not direct prevention of infection. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

344 people

The number who actually took part.

Started

Oct 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 11 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease Coronaviridae Infections Infections lung disorder respiratory system disorder respiratory tract infectious disorder viral infectious disease COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 SARS CoV 2 infection

Contacts and locations

Locations

  • ACRC Trials

    Plano, Texas, 75024, United States

  • AMR Clinical

    Oak Brook, Illinois, 60523, United States

  • AMR Clinical

    Layton, Utah, 84041, United States

  • Bio-Medical Research LLC

    Miami, Florida, 33144, United States

  • C & R Research USA

    Homestead, Florida, 33030, United States

  • California Research Foundation

    San Diego, California, 92123, United States

  • Cincinnati Children's Hospital Medical Center- Infectious Disease

    Cincinnati, Ohio, 45206, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402, United States

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226, United States

  • Clinical Research Puerto Rico

    Guayama, Puerto RICO, 00784, Puerto Rico

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • DM Clinical Research- Cyfair

    Houston, Texas, 77065, United States

  • Dayton Clinical Research

    Dayton, Ohio, 45409, United States

  • Florida Pharmaceutical Research and Associates

    Miami, Florida, 33143, United States

  • GCP Research, Global Clinical professionals

    St. Petersburg, Florida, 33714, United States

  • Indago Research & Health Center, Inc

    Miami Lakes, Florida, 33016, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121, United States

  • Javara - Privia Medical Group North Texas - Stephenville

    Stephenville, Texas, 76401, United States

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • Medical Research Partners

    Ammon, Idaho, 83406, United States

  • Michigan Center of Medical Research (MICHMER)

    Bingham Farms, Michigan, 48025, United States

  • Ponce Medical School Foundation Inc.

    Ponce, Puerto RICO, 00716, Puerto Rico

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • Stanford University Medical Center CTRU - 800 Welch Road

    Palo Alto, California, 94304, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Tekton Research, LLC.

    Richmond, Virginia, 23233, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

More trials for these conditions

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