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One shot for two threats: combined COVID-Flu vaccine moves to final testing

NCT ID NCT06178991

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a single combined vaccine that aims to protect against both COVID-19 and influenza. About 8,800 healthy adults received either the combo shot or separate vaccines. Researchers checked for side effects and measured immune responses over six months to see if the combined approach is safe and works as well as separate shots.

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

8,795 people

The number who actually took part.

Started

Dec 2023

Finished

Nov 2024

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 to 64 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.

Inclusion Criteria: * Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria: * Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. * Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration. Please 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 Influenza

Contacts and locations

Locations

  • ACRC TRIALS / North Texas Family Medicine

    Plano, Texas, 75093, United States

  • ACRC Trials (Administrative Location)

    Plano, Texas, 75024, United States

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia, 30328, United States

  • AIM Trials, LLC

    Plano, Texas, 75093, United States

  • AMR Clinical

    Mobile, Alabama, 36608, United States

  • AMR Clinical

    Wichita, Kansas, 67207, United States

  • AMR Clinical

    Layton, Utah, 84041, United States

  • AMR Clinical

    Norfolk, Virginia, 23502, United States

  • Accel Research Sites - Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216, United States

  • Accellacare - Hickory

    Hickory, North Carolina, 28601, United States

  • Accellacare - Rocky Mount

    Rocky Mount, North Carolina, 27804, United States

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina, 27103, United States

  • Acclaim Clinical Research

    San Diego, California, 92120, United States

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920, United States

  • Angels Clinical Research Institute

    Miami Lakes, Florida, 33016, United States

  • Angels Clinical Research Institute

    Tampa, Florida, 33614, United States

  • Ark Clinical Research

    Long Beach, California, 90815, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Ascada Health PC dba Ascada Research

    Fullerton, California, 92835, United States

  • Baptist Health Center For Clinical Research

    Little Rock, Arkansas, 72205, United States

  • Bayview Research Group, LLC

    Valley Village, California, 91607, United States

  • Benchmark Research

    Austin, Texas, 78705, United States

  • Benchmark Research

    Fort Worth, Texas, 76135, United States

  • Best Quality Research,Inc.

    Hialeah, Florida, 33016, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia, 31904, United States

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256, United States

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005, United States

  • Clinical Site Partners LLC, dba Flourish Research

    Miami, Florida, 33186, United States

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas, 78229, United States

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720, United States

  • DBC Research USA

    Pembroke Pines, Florida, 33029, United States

  • DFW Clinical Research

    Dallas, Texas, 75240, United States

  • DM Clinical Research, Martin Diagnostic Clinic

    Tomball, Texas, 77375, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • Entrust Clinical Research

    Miami, Florida, 33176, United States

  • Finlay Medical Research

    Greenacres City, Florida, 33467, United States

  • Foothills Research Center/ CCT Research

    Phoenix, Arizona, 85044, United States

  • Gerardo Polanco, MD

    Miami, Florida, 33156, United States

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640, United States

  • HOPE Research Institute

    Phoenix, Arizona, 85032, United States

  • Headlands Horizons, LLC dba Headlands Research-Brownsville

    Brownsville, Texas, 78526, United States

  • Headlands Research - Detroit

    Southfield, Michigan, 48034, United States

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606, United States

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303, United States

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059, United States

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012, United States

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157, United States

  • Internal Medicine and Pediatric Associates of Bristol

    Bristol, Tennessee, 37620, United States

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

    Salt Lake City, Utah, 84121, United States

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904, United States

  • Koch Family Medicine

    Morton, Illinois, 61550, United States

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030, United States

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112, United States

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612, United States

  • McGill Family Practice

    Papillion, Nebraska, 68046, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • New Phase Research and Development

    Knoxville, Tennessee, 37909, United States

  • North Alabama Research Center

    Athens, Alabama, 35611, United States

  • Northwest Houston Heart Center

    Tomball, Texas, 77375, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Orion Clinical Research

    Austin, Texas, 78759, United States

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014, United States

  • Pharmaron

    Baltimore, Maryland, 21201, United States

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308, United States

  • Quality Clinical Research

    Omaha, Nebraska, 68114, United States

  • Research Institute of South Florida

    Miami, Florida, 33173, United States

  • Revival Research Institute, LLC

    Sterling Heights, Michigan, 48312, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

  • SMS Clinical Research

    Mesquite, Texas, 75149, United States

  • Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104, United States

  • Santa Clara Family Clinic

    Houston, Texas, 77087, United States

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • Sundance Clinical Research

    St Louis, Missouri, 63141, United States

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083, United States

  • Synexus Clinical Research US, Inc.

    Chicago, Illinois, 60602, United States

  • Synexus Clinical Research US, Inc.

    Cincinnati, Ohio, 45236, United States

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761, United States

  • Tekton Research, LLC.

    Austin, Texas, 78745, United States

  • Texas Health Family Care

    Fort Worth, Texas, 76135, United States

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572, United States

  • Trial Management Associates - Wilmington - Floral Parkway

    Wilmington, North Carolina, 28403, United States

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403, United States

  • Trial Management Associates, LLC

    Myrtle Beach, South Carolina, 29572, United States

  • Universal Axon Clinical Research, LLC

    Doral, Florida, 33166, United States

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, Ohio, 45219, United States

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106, United States

More trials for these conditions

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