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One shot for two threats? BioNTech tests combo Flu-COVID vaccine

NCT ID NCT06821061

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested new modified RNA vaccines that target both influenza and COVID-19, given as a single shot. Over 2,600 healthy adults aged 18 and older took part, receiving either a flu vaccine, a COVID-19 vaccine, or a combination of both. The main goal was to check safety and how well the body's immune system responds, with results expected to guide future vaccine development.

What this could mean

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

Active substance
modified RNA vaccine (combined influenza and COVID-19)
What this could lead to
If successful, this could lead to a single annual shot that protects against both flu and COVID-19, simplifying vaccination schedules.
What could go wrong
This is an early-phase trial focused on safety and immune response, not yet proven to prevent illness. The combined vaccine may not work as well as separate shots, and side effects are still being evaluated.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

2,650 people

The number who actually took part.

Started

Feb 2025

Finished

Dec 2025

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

18 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: * Participants 18 years of age or older * Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study Exclusion criteria: * Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment * Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment. * Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1. 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 influenza prevention target

As listed by the trial registrant

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

COVID-19 (coronavirus disease 2019) Influenza

Contacts and locations

Locations

  • AMR Clinical

    Knoxville, Tennessee, 37909, United States

  • AMR Clinical

    Knoxville, Tennessee, 37920, United States

  • Alliance for Multispecialty Research, LLC

    Doral, Florida, 33172, United States

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801, United States

  • Artemis Institute for Clinical Research

    Riverside, California, 92503, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213, United States

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911, United States

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203, United States

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Consulting

    Milford, Connecticut, 06460, United States

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, 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

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Tomball, Texas, 77375, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • Headlands Horizons, LLC dba Headlands Research-Brownsville

    Brownsville, Texas, 78526, 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

  • Kaiser Permanente Washington Health Research Institute (KPWHRI)

    Seattle, Washington, 98101, United States

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030, United States

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014, United States

  • SMS Clinical Research

    Mesquite, Texas, 75149, United States

  • Trial Management Associates - Wilmington - Floral Parkway

    Wilmington, North Carolina, 28403, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Upstate Global Health Institute

    East Syracuse, New York, 13057, United States

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