A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

Last updated: December 11, 2024
Sponsor: BioNTech SE
Overall Status: Completed

Phase

3

Condition

Influenza

Covid-19

Treatment

Placebo

Licensed influenza vaccine

Investigational influenza vaccine

Clinical Study ID

NCT06178991
C5261002
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.

Cohort 1: Approximately 450 participants will be assigned by chance to one of the following:

  • Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm.

  • Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm.

Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following:

  • Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm.

  • Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.

Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:

  • Group E: Influenza and COVID-19 combination B vaccine.

  • Group F: COVID-19 vaccine.

  • Group G: Licenced influenza vaccine.

  • Group H: Investigational influenza vaccine.

All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants 18 through 64 years of age (or the minimum age of consent in accordancewith local regulations) at Visit 1.

  • Healthy participants who are determined by medical history, physical examination (ifrequired), and clinical judgment of the investigator to be eligible for inclusion inthe study.

Exclusion

Exclusion Criteria:

  • Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronicantiviral 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

Study Design

Total Participants: 8798
Treatment Group(s): 6
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 20, 2023
Estimated Completion Date:
November 26, 2024

Connect with a study center

  • North Alabama Research Center

    Athens, Alabama 35611
    United States

    Site Not Available

  • Accel Research Sites - Birmingham Clinical Research Unit

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Accel Research Sites Network - Birmingham Clinical Research Unit

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Medical Affiliated Research Center

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Foothills Research Center/ CCT Research

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • HOPE Research Institute

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • The Pain Center of Arizona

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Baptist Health Center For Clinical Research

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Velocity Clinical Research, Banning

    Banning, California 92220
    United States

    Site Not Available

  • Hope Clinical Research, Inc.

    Canoga Park, California 91303
    United States

    Site Not Available

  • West Coast Research

    Dublin, California 94568
    United States

    Site Not Available

  • Ascada Health PC dba Ascada Research

    Fullerton, California 92835
    United States

    Site Not Available

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Velocity Clinical Research, San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • Velocity Clinical Research, Westlake

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California 91606
    United States

    Site Not Available

  • Pasadena Clinical Trials - South Arroyo Parkway

    Pasadena, California 91105
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Site Not Available

  • Benchmark Research

    Sacramento, California 95864
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Optimal Research San Diego

    San Diego, California 92108
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Bayview Research Group, LLC

    Valley Village, California 91607
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Vista, California 92083
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Clinical Research Consulting

    Milford, Connecticut 06460
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Universal Axon Clinical Research, LLC

    Doral, Florida 33166
    United States

    Site Not Available

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Finlay Medical Research

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Best Quality Research,Inc.

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Indago Research & Health Center, Inc

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Research Centers of America ( Hollywood )

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Optimal Research

    Melbourne, Florida 32934
    United States

    Site Not Available

  • Angels Clinical Research Institute

    Miami, Florida 33122
    United States

    Site Not Available

  • Clinical Site Partners LLC, dba Flourish Research

    Miami, Florida 33186
    United States

    Site Not Available

  • Entrust Clinical Research

    Miami, Florida 33176
    United States

    Site Not Available

  • Gerardo Polanco, MD

    Miami, Florida 33156
    United States

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida 33176
    United States

    Site Not Available

  • Research Institute of South Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • Angels Clinical Research Institute

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Palm Springs Community Health Center

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Panax Clinical Research

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • DBC Research USA

    Pembroke Pines, Florida 33029
    United States

    Site Not Available

  • United Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Angels Clinical Research Institute

    Tampa, Florida 33614
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Tekton Research, LLC.

    Lawrenceville, Georgia 30043
    United States

    Site Not Available

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Velocity Clinical Research, Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Velocity Clinical Research, Boise

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Koch Family Medicine

    Morton, Illinois 61550
    United States

    Site Not Available

  • Affinity Health

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Pharmaron

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Advanced Primary and Geriatric Care - CCT Research

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Jadestone Clinical Research

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Michigan Center of Medical Research (MICHMER)

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Headlands Research - Detroit

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Revival Research Institute

    Sterling Heights, Michigan 48312
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Sterling Heights, Michigan 48312
    United States

    Site Not Available

  • Oakland Medical Research

    Troy, Michigan 48085
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Saint Louis University Center for Vaccine Development

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Sundance Clinical Research

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • DelRicht Research

    Springfield, Missouri 65807
    United States

    Site Not Available

  • DelRicht Research - Springfield

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • McGill Family Practice

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Excel Clinical Research, LLC

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Wr-Crcn, Llc

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada 89030
    United States

    Site Not Available

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • IMA Clinical Research Warren

    Warren, New Jersey 07059
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Duke Vaccine and Trials Unit

    Durham, North Carolina 27703
    United States

    Site Not Available

  • Accellacare - Hickory

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Accellacare - Rocky Mount

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • Accellacare - Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Accellacare - Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Trial Management Associates - Wilmington - Floral Parkway

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Trial Management Associates, LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Lynn Institute of Norman

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Main Street Physician's Care

    Little River, South Carolina 29566
    United States

    Site Not Available

  • Trial Management Associates

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Trial Management Associates, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Internal Medicine and Pediatric Associates of Bristol

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Accellacare US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee 37912
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • New Phase Research and Development

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Benchmark Research

    Austin, Texas 78705
    United States

    Site Not Available

  • Optimal Research

    Austin, Texas 78744
    United States

    Site Not Available

  • Orion Clinical Research

    Austin, Texas 78759
    United States

    Site Not Available

  • Tekton Research, LLC.

    Austin, Texas 78745
    United States

    Site Not Available

  • Headlands Horizons LLC

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Headlands Horizons, LLC dba Headlands Research-Brownsville

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Headlands Research - Brownsville

    Brownsville, Texas 78526
    United States

    Active - Recruiting

  • ACRC TRIALS / Family Medicine Associates of Texas

    Carrollton, Texas 75010
    United States

    Site Not Available

  • DFW Clinical Research

    Dallas, Texas 75240
    United States

    Site Not Available

  • North Texas Infectious Diseases Consultants, P.A

    Dallas, Texas 75246
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Dallas, Texas 75234
    United States

    Site Not Available

  • Benchmark Research

    Fort Worth, Texas 76135
    United States

    Site Not Available

  • Texas Health Family Care

    Fort Worth, Texas 76135
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • DM Clinical Research - Bellaire

    Houston, Texas 77081
    United States

    Site Not Available

  • Santa Clara Family Clinic

    Houston, Texas 77087
    United States

    Site Not Available

  • SMS Clinical Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • ACRC TRIALS / North Texas Family Medicine

    Plano, Texas 75093
    United States

    Site Not Available

  • ACRC Trials (Administrative Location)

    Plano, Texas 75024
    United States

    Site Not Available

  • AIM Trials, LLC

    Plano, Texas 75093
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • IMA Clinical Research San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sugar Lakes Family Practice, PA

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • DM Clinical Research - MDC

    Tomball, Texas 77375
    United States

    Site Not Available

  • Northwest Houston Heart Center

    Tomball, Texas 77375
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Layton, Utah 84041
    United States

    Site Not Available

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

    Salt Lake City, Utah 84109
    United States

    Site Not Available

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

    Salt Lake City, Utah 84121
    United States

    Site Not Available

  • J. Lewis Research, Inc. / Jordan River Family Medicine

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Clinical Research Partners, LLC

    Richmond, Virginia 23226
    United States

    Site Not Available

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