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NCT06178991 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06178991
Other study ID # C5261002
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 20, 2023
Est. completion date November 14, 2024

Study information
Verified date June 2024
Source BioNTech SE
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 7134
Est. completion date November 14, 2024
Est. primary completion date November 14, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Influenza and COVID-19 Combination A
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
• Licensed influenza vaccine
Licensed influenza vaccine
• COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine
• Influenza and COVID-19 Combination B
Combined influenza and Pfizer-BioNTech COVID-19 vaccine
• Placebo
Saline Solution
• Investigational influenza vaccine
Investigational influenza vaccine

Locations
Country Name City State
United States Albuquerque Clinical Trials, Inc. Albuquerque New Mexico
United States North Alabama Research Center Athens Alabama
United States Synexus Clinical Research US, Inc. Atlanta Georgia
United States Benchmark Research Austin Texas
United States Optimal Research Austin Texas
United States Orion Clinical Research Austin Texas
United States Tekton Research, LLC. Austin Texas
United States Pharmaron Baltimore Maryland
United States Velocity Clinical Research, Banning Banning California
United States Accel Research Sites Network - Birmingham Clinical Research Unit Birmingham Alabama
United States Internal Medicine and Pediatric Associates of Bristol Bristol Tennessee
United States Headlands Horizons LLC Brownsville Texas
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Hope Clinical Research, Inc. Canoga Park California
United States ACRC TRIALS / Family Medicine Associates of Texas Carrollton Texas
United States Charlottesville Medical Research Charlottesville Virginia
United States Clinical Research Professionals Chesterfield Missouri
United States Great Lakes Clinical Trials - Ravenswood Chicago Illinois
United States Synexus Clinical Research US, Inc. Chicago Illinois
United States CTI Clinical Research Center Cincinnati Ohio
United States Synexus Clinical Research US, Inc. Cincinnati Ohio
United States Velocity Clinical Research, Mt. Auburn Cincinnati Ohio
United States Tampa Bay Medical Research Clearwater Florida
United States Centricity Research Columbus Georgia Multispecialty Columbus Georgia
United States Centricity Research Columbus Ohio Multispecialty Columbus Ohio
United States DFW Clinical Research Dallas Texas
United States North Texas Infectious Diseases Consultants, P.A Dallas Texas
United States Synexus Clinical Research US, Inc. Dallas Texas
United States Universal Axon Clinical Research, LLC Doral Florida
United States West Coast Research Dublin California
United States Duke Vaccine and Trials Unit Durham North Carolina
United States Michigan Center of Medical Research (MICHMER) Farmington Hills Michigan
United States Proactive Clinical Research,LLC Fort Lauderdale Florida
United States Benchmark Research Fort Worth Texas
United States Texas Health Family Care Fort Worth Texas
United States Ascada Health PC dba Ascada Research Fullerton California
United States University of Texas Medical Branch Galveston Texas
United States Velocity Clinical Research, Grand Island Grand Island Nebraska
United States Finlay Medical Research Greenacres City Florida
United States Great Lakes Clinical Trials - Gurnee Gurnee Illinois
United States Best Quality Research,Inc. Hialeah Florida
United States Indago Research & Health Center, Inc Hialeah Florida
United States Accellacare - Hickory Hickory North Carolina
United States Research Centers of America ( Hollywood ) Hollywood Florida
United States East-West Medical Research Institute Honolulu Hawaii
United States DM Clinical Research - Bellaire Houston Texas
United States Santa Clara Family Clinic Houston Texas
United States Marvel Clinical Research Huntington Beach California
United States Medical Affiliated Research Center Huntsville Alabama
United States Clinical Research Prime Idaho Falls Idaho
United States Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Jacksonville Florida
United States Alliance for Multispecialty Research, LLC Kansas City Missouri
United States Accellacare US Inc., d/b/a Accellacare of Knoxville Knoxville Tennessee
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States New Phase Research and Development Knoxville Tennessee
United States Velocity Clinical Research, San Diego La Mesa California
United States Orange County Research Center Lake Forest California
United States Excel Clinical Research, LLC Las Vegas Nevada
United States Las Vegas Clinical Trials Las Vegas Nevada
United States Wr-Crcn, Llc Las Vegas Nevada
United States Tekton Research, LLC. Lawrenceville Georgia
United States Alliance for Multispecialty Research, LLC Layton Utah
United States Main Street Physician's Care Little River South Carolina
United States Baptist Health Center for Clinical Research Little Rock Arkansas
United States Ark Clinical Research Long Beach California
United States Collaborative Neuroscience Research, LLC Los Alamitos California
United States Kaiser Permanente Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Velocity Clinical Research, Westlake Los Angeles California
United States Velocity Clinical Research, Medford Medford Oregon
United States Optimal Research Melbourne Florida
United States Clinical Neuroscience Solutions Inc. Memphis Tennessee
United States Solaris Clinical Research Meridian Idaho
United States Velocity Clinical Research, Boise Meridian Idaho
United States SMS Clinical Research Mesquite Texas
United States Angels Clinical Research Institute Miami Florida
United States Clinical Site Partners LLC, dba Flourish Research Miami Florida
United States Entrust Clinical Research Miami Florida
United States Gerardo Polanco, MD Miami Florida
United States Miami Clinical Research Miami Florida
United States Miami Dade Medical Research Institute, LLC Miami Florida
United States Research Institute of South Florida Miami Florida
United States Palm Springs Community Health Center Miami Lakes Florida
United States Panax Clinical Research Miami Lakes Florida
United States Clinical Research Consulting Milford Connecticut
United States Alliance for Multispecialty Research, LLC Mobile Alabama
United States Monroe Biomedical Research Monroe North Carolina
United States Koch Family Medicine Morton Illinois
United States Trial Management Associates Myrtle Beach South Carolina
United States NYU Langone Health New York New York
United States Health Research of Hampton Roads, Inc. Newport News Virginia
United States Alliance for Multispecialty Research, LLC Norfolk Virginia
United States Lynn Institute of Norman Norman Oklahoma
United States Coastal Carolina Research Center North Charleston South Carolina
United States Velocity Clinical Research, North Hollywood North Hollywood California
United States Las Vegas Clinical Trials North Las Vegas Nevada
United States Affinity Health Oak Brook Illinois
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Quality Clinical Research Omaha Nebraska
United States Velocity Clinical Research, Omaha Omaha Nebraska
United States Clinical Neuroscience Solutions, Inc. Orlando Florida
United States Innovation Medical Research Center Palmetto Bay Florida
United States McGill Family Practice Papillion Nebraska
United States Pasadena Clinical Trials - South Arroyo Parkway Pasadena California
United States DBC Research USA Pembroke Pines Florida
United States DM Clinical Research - Philadelphia Philadelphia Pennsylvania
United States Foothills Research Center/ CCT Research Phoenix Arizona
United States HOPE Research Institute Phoenix Arizona
United States The Pain Center of Arizona Phoenix Arizona
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 United Medical Research Port Orange Florida
United States ActivMed Practices & Research, LLC. Portsmouth New Hampshire
United States M3 Wake Research, Inc. Raleigh North Carolina
United States Clinical Research Partners, LLC Richmond Virginia
United States Artemis Institute for Clinical Research Riverside California
United States Rochester Clinical Research, LLC Rochester New York
United States Advanced Primary and Geriatric Care - CCT Research Rockville Maryland
United States Accellacare - Rocky Mount Rocky Mount North Carolina
United States Benchmark Research Sacramento California
United States Saint Louis University Center for Vaccine Development Saint Louis Missouri
United States Sundance Clinical Research Saint Louis Missouri
United States Accellacare - Salisbury Salisbury North Carolina
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 Clinical Trials of Texas, LLC San Antonio Texas
United States IMA Clinical Research San Antonio San Antonio Texas
United States Acclaim Clinical Research San Diego California
United States Artemis Institute for Clinical Research San Diego California
United States Optimal Research San Diego San Diego California
United States AGILE Clinical Research Trials, LLC Sandy Springs Georgia
United States Velocity Clinical Research, Savannah Savannah Georgia
United States Scottsdale Clinical Trials Scottsdale Arizona
United States Jadestone Clinical Research Silver Spring Maryland
United States Velocity Clinical Research, Sioux City Sioux City Iowa
United States J. Lewis Research, Inc. / Jordan River Family Medicine South Jordan Utah
United States Headlands Research - Detroit Southfield Michigan
United States DelRicht Research Springfield Missouri
United States DelRicht Research - Springfield Springfield Missouri
United States Revival Research Institute, LLC Sterling Heights Michigan
United States Clinical Research Atlanta Stockbridge Georgia
United States Sugar Lakes Family Practice, PA Sugar Land Texas
United States Angels Clinical Research Institute Tampa Florida
United States Alliance for Multispecialty Research, LLC Tempe Arizona
United States DM Clinical Research Tomball Texas
United States Northwest Houston Heart Center Tomball Texas
United States Oakland Medical Research Troy Michigan
United States Orange County Research Center Tustin California
United States Bayview Research Group, LLC Valley Village California
United States Diablo Clinical Research, Inc. Walnut Creek California
United States IMA Clinical Research Warren Warren New Jersey
United States Velocity Clinical Research, Salt Lake City West Jordan Utah
United States Alliance for Multispecialty Research, LLC Wichita Kansas
United States Accellacare - Wilmington Wilmington North Carolina
United States Trial Management Associates - Wilmington - Floral Parkway Wilmington North Carolina
United States Trial Management Associates, LLC Wilmington North Carolina
United States Accellacare - Winston-Salem Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
BioNTech SE Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants reporting prompted local reactions within 7 days following investigational product administration Describe prompted local reactions following investigational product administration Day 7
Primary Percentage of participants reporting prompted systemic events within 7 days following investigational product administration Describe prompted systemic events following investigational product administration Day 7
Primary Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration Describe AEs occurring through 4 weeks following administration of investigational product 4 weeks after vaccination
Primary Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration Describe SAEs through 6 months following administration of investigational product 6 months after vaccination
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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