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History of Changes for Study: NCT06178991
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Latest version (submitted April 16, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 20, 2023 None (earliest Version on record)
2 January 22, 2024 Recruitment Status, Contacts/Locations, Study Status and Oversight
3 February 6, 2024 Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Study Design and Study Description
4 April 16, 2024 Study Status, Contacts/Locations and Study Design
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Study NCT06178991
Submitted Date:  December 20, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: C5261002
Brief Title: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2023
Overall Status: Not yet recruiting
Study Start: December 21, 2023
Primary Completion: August 30, 2024 [Anticipated]
Study Completion: August 30, 2024 [Anticipated]
First Submitted: December 20, 2023
First Submitted that
Met QC Criteria:		 December 20, 2023
First Posted: December 21, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 December 20, 2023
Last Update Posted: December 21, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioNTech SE
Responsible Party: Sponsor
Collaborators: Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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 7500 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance.

Cohort 1: Around 4500 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 the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm.
  • Group B: Licensed influenza vaccine, given at the same time to the right arm and COVID-19 Vaccine in the left arm.

Cohort 2: Around 3000 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 the right arm and placebo in the left arm.
  • Group D: Licensed influenza vaccine, given at the same time in the right arm and COVID-19 in the left arm.

All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.
Detailed Description:
Open or close this module Conditions
Conditions: Influenza
COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 7500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
 Biological: Influenza and COVID-19 Combination A
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
Biological: Placebo
Saline Solution
Active Comparator: Cohort 1 Arm B: Licensed influenza vaccine and COVID-19 concomitant administration group
Cohort 1 Arm B: Licensed influenza vaccine and COVID-19 concomitant administration group
 Biological: Licensed influenza vaccine
Licensed influenza vaccine
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine
Experimental: Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
 Biological: Influenza and COVID-19 Combination B
Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Biological: Placebo
Saline Solution
Active Comparator: Cohort 2 Arm D: Licensed influenza vaccine and COVID-19 concomitant administration group
Cohort 2 Arm D: Licensed influenza vaccine and COVID-19 concomitant administration group
 Biological: Licensed influenza vaccine
Licensed influenza vaccine
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of participants reporting prompted local reactions within 7 days following investigational product administration in the right deltoid
[ Time Frame: Day 7 ]

Describe prompted local reactions following investigational product administration
2. Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
[ Time Frame: Day 7 ]

Describe prompted systemic events following investigational product administration
3. Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
[ Time Frame: 4 weeks after vaccination ]

Describe AEs occurring through 4 weeks following administration of investigational product
4. Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
[ Time Frame: 6 months after vaccination ]

Describe SAEs through 1 month following administration of investigational product
5. GMR of HAI titers in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by licensed influenza vaccine and COVID-19 concomitant administration group
6. The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by Licensed influenza vaccine and COVID-19 concomitant administration group.
7. GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination A recipients compared to participants having received licensed influenza vaccine and COVID-19 concomitant administration group at 4 weeks after vaccination
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
8. The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to subjects having received licensed influenza vaccine and COVID-19 concomitant administration group
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
9. GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19
10. 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
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19
11. 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
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
12. 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
[ Time Frame: 4 weeks after vaccination ]

To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 64 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, Alabama
North Alabama Research Center
Athens, Alabama, United States, 35611
Accel Research Sites Network - Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35216
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85018
The Pain Center of Arizona
Phoenix, Arizona, United States, 85018
Foothills Research Center/ CCT Research
Phoenix, Arizona, United States, 85044
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States, 85281
United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Velocity Clinical Research, Banning
Banning, California, United States, 92220
Hope Clinical Research, Inc.
Canoga Park, California, United States, 91303
Ascada Health PC dba Ascada Research
Fullerton, California, United States, 92835
Marvel Clinical Research
Huntington Beach, California, United States, 92647
Velocity Clinical Research, San Diego
La Mesa, California, United States, 91942
Ark Clinical Research
Long Beach, California, United States, 90815
Velocity Clinical Research, Westlake
Los Angeles, California, United States, 90057
Velocity Clinical Research, North Hollywood
North Hollywood, California, United States, 91606
Benchmark Research
Sacramento, California, United States, 95864
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Optimal Research San Diego
San Diego, California, United States, 92108
Acclaim Clinical Research
San Diego, California, United States, 92120
Orange County Research Center
Tustin, California, United States, 92780
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Connecticut
Clinical Research Consulting
Milford, Connecticut, United States, 06460
United States, Florida
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States, 33308
Finlay Medical Research
Greenacres City, Florida, United States, 33467
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
Best Quality Research,Inc.
Hialeah, Florida, United States, 33016
Research Centers of America ( Hollywood )
Hollywood, Florida, United States, 33024
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States, 32256
Optimal Research
Melbourne, Florida, United States, 32934
Angels Clinical Research Institute
Miami, Florida, United States, 33122
Miami Clinical Research
Miami, Florida, United States, 33155
Gerardo Polanco, MD
Miami, Florida, United States, 33156
Research Institute of South Florida
Miami, Florida, United States, 33173
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States, 33176
Clinical Site Partners LLC, dba Flourish Research
Miami, Florida, United States, 33186
Palm Springs Community Health Center
Miami Lakes, Florida, United States, 33014
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Innovation Medical Research Center
Palmetto Bay, Florida, United States, 33157
DBC Research USA
Pembroke Pines, Florida, United States, 33029
United Medical Research
Port Orange, Florida, United States, 32127
Angels Clinical Research Institute
Tampa, Florida, United States, 33614
United States, Georgia
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States, 31904
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
Velocity Clinical Research, Boise
Meridian, Idaho, United States, 83642
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Illinois
Synexus Clinical Research US, Inc.
Chicago, Illinois, United States, 60602
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States, 60640
Koch Family Medicine
Morton, Illinois, United States, 61550
Affinity Health
Oak Brook, Illinois, United States, 60523
United States, Kansas
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States, 67207
United States, Maryland
Pharmaron
Baltimore, Maryland, United States, 21201
Jadestone Clinical Research
Silver Spring, Maryland, United States, 20904
United States, Michigan
Michigan Center of Medical Research (MICHMER)
Farmington Hills, Michigan, United States, 48334
Headlands Research - Detroit
Southfield, Michigan, United States, 48034
Revival Research Institute
Sterling Heights, Michigan, United States, 48312
Oakland Medical Research
Troy, Michigan, United States, 48085
United States, Missouri
Clinical Research Professionals
Chesterfield, Missouri, United States, 63005
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States, 64114
Sundance Clinical Research
Saint Louis, Missouri, United States, 63141
DelRicht Research - Springfield
Springfield, Missouri, United States, 65807
DelRicht Research
Springfield, Missouri, United States, 65807
United States, Nebraska
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
McGill Family Practice
Papillion, Nebraska, United States, 68046
United States, Nevada
Excel Clinical Research, LLC
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
IMA Clinical Research Warren
Warren, New Jersey, United States, 07059
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
United States, New York
Rochester Clinical Research, LLC
Rochester, New York, United States, 14609
United States, North Carolina
Accellacare - Hickory
Hickory, North Carolina, United States, 28601
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Accellacare - Rocky Mount
Rocky Mount, North Carolina, United States, 27804
Accellacare - Salisbury
Salisbury, North Carolina, United States, 28144
Accellacare - Wilmington
Wilmington, North Carolina, United States, 28401
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, United States, 28403
Accellacare - Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Synexus Clinical Research US, Inc.
Cincinnati, Ohio, United States, 45236
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States, 43213
United States, Oklahoma
Lynn Institute of Norman
Norman, Oklahoma, United States, 73072
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Velocity Clinical Research, Medford
Medford, Oregon, United States, 97504
United States, Pennsylvania
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Main Street Physician's Care
Little River, South Carolina, United States, 29566
Trial Management Associates
Myrtle Beach, South Carolina, United States, 29572
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
United States, Tennessee
Internal Medicine and Pediatric Associates of Bristol
Bristol, Tennessee, United States, 37620
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States, 37909
New Phase Research and Development
Knoxville, Tennessee, United States, 37909
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, United States, 37912
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States, 37920
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Tekton Research, LLC.
Austin, Texas, United States, 78745
Orion Clinical Research
Austin, Texas, United States, 78759
Headlands Research - Brownsville
Brownsville, Texas, United States, 78526
ACRC TRIALS / Family Medicine Associates of Texas
Carrollton, Texas, United States, 75010
DFW Clinical Research
Dallas, Texas, United States, 75234
Synexus Clinical Research US, Inc.
Dallas, Texas, United States, 75234
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, United States, 75246
Santa Clara Family Clinic
Houston, Texas, United States, 77087
SMS Clinical Research
Mesquite, Texas, United States, 75149
ACRC Trials (Administrative Location)
Plano, Texas, United States, 75024
AIM Trials, LLC
Plano, Texas, United States, 75093
Sugar Lakes Family Practice, PA
Sugar Land, Texas, United States, 77479
DM Clinical Research
Tomball, Texas, United States, 77375
Northwest Houston Heart Center
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States, 84095
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States, 23606
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
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Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services