A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
- Conditions
- InfluenzaCOVID-19
- Interventions
- Biological: Licensed influenza vaccineBiological: Influenza and COVID-19 Combination ABiological: Influenza and COVID-19 Combination BBiological: Investigational influenza vaccineBiological: Placebo
- Registration Number
- NCT06178991
- Lead Sponsor
- BioNTech SE
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8798
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group Licensed influenza vaccine Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group Cohort 3 Arm F: COVID-19 vaccine COVID-19 Vaccine Cohort 3 Arm F: COVID-19 vaccine Cohort 3 Arm G: Licensed influenza vaccine Licensed influenza vaccine Cohort 3 Arm G: Licensed influenza vaccine Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo Influenza and COVID-19 Combination A Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo Placebo Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo Influenza and COVID-19 Combination B Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo Placebo Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo Cohort 3 Arm E:Influenza and COVID-19 Combination B Influenza and COVID-19 Combination B Cohort 3 Arm E:Influenza and COVID-19 Combination B Cohort 3 Arm H: Investigational influenza vaccine Investigational influenza vaccine Cohort 3 Arm H: Investigational influenza vaccine Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group COVID-19 Vaccine Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group COVID-19 Vaccine Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group Licensed influenza vaccine Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
- Primary Outcome Measures
Name Time Method Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration 4 weeks after vaccination Describe AEs occurring through 4 weeks following administration of investigational product
GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination 4 weeks after vaccination GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination 4 weeks after vaccination The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination Percentage of participants reporting prompted systemic events within 7 days following investigational product administration Day 7 Describe prompted systemic events following investigational product administration
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration 6 months after vaccination Describe SAEs through 6 months following administration of investigational product
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration Day 7 Describe prompted local reactions following investigational product administration
The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19 4 weeks after vaccination
- Secondary Outcome Measures
Name Time Method GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine alone 4 weeks after vaccination GMR of SARS-CoV-2-neutralizing titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received COVID-19 vaccine alone 4 weeks after vaccination GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received investigational influenza vaccine alone 4 weeks after vaccination GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine concomitantly with COVID-19 vaccine 4 weeks after vaccination Difference in percentage of participants with seroconversion at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to licensed influenza vaccine administered concomitantly with COVID-19 vaccine recipients 4 weeks after vaccination
Trial Locations
- Locations (144)
Velocity Clinical Research, Cincinnati, Mt. Auburn
🇺🇸Cincinnati, Ohio, United States
North Alabama Research Center
🇺🇸Athens, Alabama, United States
Accel Research Sites - Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norfolk, Virginia, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
The Pain Center of Arizona
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Foothills Research Center/ CCT Research
🇺🇸Phoenix, Arizona, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
Baptist Health Center For Clinical Research
🇺🇸Little Rock, Arkansas, United States
Velocity Clinical Research, Banning
🇺🇸Banning, California, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
West Coast Research
🇺🇸Dublin, California, United States
Ascada Health PC dba Ascada Research
🇺🇸Fullerton, California, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Velocity Clinical Research, San Diego
🇺🇸La Mesa, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Los Alamitos, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸North Hollywood, California, United States
Pasadena Clinical Trials - South Arroyo Parkway
🇺🇸Pasadena, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
Optimal Research San Diego
🇺🇸San Diego, California, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
Bayview Research Group, LLC
🇺🇸Valley Village, California, United States
Synexus Clinical Research US, Inc.
🇺🇸Dallas, Texas, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Universal Axon Clinical Research, LLC
🇺🇸Doral, Florida, United States
Proactive Clinical Research,LLC
🇺🇸Fort Lauderdale, Florida, United States
Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Best Quality Research,Inc.
🇺🇸Hialeah, Florida, United States
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Optimal Research
🇺🇸Austin, Texas, United States
Palm Springs Community Health Center
🇺🇸Miami Lakes, Florida, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Angels Clinical Research Institute
🇺🇸Tampa, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
Gerardo Polanco, MD
🇺🇸Miami, Florida, United States
Research Institute of South Florida
🇺🇸Miami, Florida, United States
Entrust Clinical Research
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Clinical Site Partners LLC, dba Flourish Research
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
DBC Research USA
🇺🇸Pembroke Pines, Florida, United States
United Medical Research
🇺🇸Port Orange, Florida, United States
Centricity Research Columbus Georgia Multispecialty
🇺🇸Columbus, Georgia, United States
Tekton Research, LLC.
🇺🇸Austin, Texas, United States
AGILE Clinical Research Trials, LLC
🇺🇸Sandy Springs, Georgia, United States
Velocity Clinical Research, Savannah
🇺🇸Savannah, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Velocity Clinical Research, Boise
🇺🇸Meridian, Idaho, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Great Lakes Clinical Trials - Ravenswood
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials - Gurnee
🇺🇸Gurnee, Illinois, United States
Koch Family Medicine
🇺🇸Morton, Illinois, United States
Affinity Health
🇺🇸Oak Brook, Illinois, United States
Velocity Clinical Research, Sioux City
🇺🇸Sioux City, Iowa, United States
Pharmaron
🇺🇸Baltimore, Maryland, United States
Advanced Primary and Geriatric Care - CCT Research
🇺🇸Rockville, Maryland, United States
Jadestone Clinical Research
🇺🇸Silver Spring, Maryland, United States
Michigan Center of Medical Research (MICHMER)
🇺🇸Farmington Hills, Michigan, United States
Headlands Research - Detroit
🇺🇸Southfield, Michigan, United States
Revival Research Institute, LLC
🇺🇸Sterling Heights, Michigan, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Saint Louis University Center for Vaccine Development
🇺🇸Saint Louis, Missouri, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
DelRicht Research - Springfield
🇺🇸Springfield, Missouri, United States
DelRicht Research
🇺🇸Springfield, Missouri, United States
Velocity Clinical Research, Grand Island
🇺🇸Grand Island, Nebraska, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Velocity Clinical Research, Omaha
🇺🇸Omaha, Nebraska, United States
McGill Family Practice
🇺🇸Papillion, Nebraska, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
Wr-Crcn, Llc
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
ActivMed Practices & Research, LLC.
🇺🇸Portsmouth, New Hampshire, United States
IMA Clinical Research Warren
🇺🇸Warren, New Jersey, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
NYU Langone Health
🇺🇸New York, New York, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Duke Vaccine and Trials Unit
🇺🇸Durham, North Carolina, United States
Accellacare - Hickory
🇺🇸Hickory, North Carolina, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Accellacare - Rocky Mount
🇺🇸Rocky Mount, North Carolina, United States
Accellacare - Salisbury
🇺🇸Salisbury, North Carolina, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
Trial Management Associates - Wilmington - Floral Parkway
🇺🇸Wilmington, North Carolina, United States
Trial Management Associates, LLC
🇺🇸Myrtle Beach, South Carolina, United States
Accellacare - Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research, Mt. Auburn
🇺🇸Cincinnati, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
🇺🇸Columbus, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
DM Clinical Research - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Main Street Physician's Care
🇺🇸Little River, South Carolina, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol
🇺🇸Bristol, Tennessee, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
🇺🇸Knoxville, Tennessee, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Orion Clinical Research
🇺🇸Austin, Texas, United States
Headlands Horizons, LLC dba Headlands Research-Brownsville
🇺🇸Brownsville, Texas, United States
ACRC TRIALS / Family Medicine Associates of Texas
🇺🇸Carrollton, Texas, United States
DFW Clinical Research
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A
🇺🇸Dallas, Texas, United States
Texas Health Family Care
🇺🇸Fort Worth, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
DM Clinical Research - Bellaire
🇺🇸Houston, Texas, United States
Santa Clara Family Clinic
🇺🇸Houston, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
ACRC Trials (Administrative Location)
🇺🇸Plano, Texas, United States
ACRC TRIALS / North Texas Family Medicine
🇺🇸Plano, Texas, United States
AIM Trials, LLC
🇺🇸Plano, Texas, United States
Clinical Trials of Texas, LLC dba Flourish Research
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice, PA
🇺🇸Sugar Land, Texas, United States
DM Clinical Research - MDC
🇺🇸Tomball, Texas, United States
Northwest Houston Heart Center
🇺🇸Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States