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New COVID-19 vaccine trial targets High-Risk groups

NCT ID NCT07069309

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an updated RNA-based COVID-19 vaccine designed for the 2025-2026 season. It involved 774 participants aged 12 and older, including those 65+ and younger people with health conditions that raise their risk of severe COVID-19. Everyone received one shot, and researchers monitored safety and immune responses over about 6 months.

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 updated COVID-19 vaccine)
What this could lead to
If successful, this could provide a safe and effective updated vaccine that better protects high-risk individuals against current COVID-19 variants.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The vaccine may not provide strong enough protection against future variants, and side effects like injection site reactions or fatigue are possible.

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

774 people

The number who actually took part.

Started

Jul 2025

Finished

May 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

12 years and older

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.

Inclusion criteria: * Cohort 1: Participants 18 years of age or older. * Cohort 2: Participants 12 years of age or older. * Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19. Exclusion Criteria: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). * History of myocarditis or pericarditis. * Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 5 months (150 days) prior to study enrollment. Refer to the study contact for further eligibility details.

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Conditions

The condition(s) this trial relates to.

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

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO

    Springfield, Missouri, 65802, United States

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center

    Springfield, Missouri, 65807, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911, United States

  • Clinical Research Consulting

    Milford, Connecticut, 06460, United States

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • DM Clinical Research- Cyfair

    Houston, Texas, 77065, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • GW Vaccine Research Unit

    Washington D.C., District of Columbia, 20037, United States

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012, 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

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • The GW Medical Faculty Associates

    Washington D.C., District of Columbia, 20037, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.