A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
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
2 other identifiers
interventional
8,795
1 country
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2023
Shorter than P25 for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
December 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2024
CompletedResults Posted
Study results publicly available
December 4, 2025
CompletedDecember 4, 2025
November 1, 2025
11 months
December 20, 2023
November 21, 2025
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (16)
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day1]
Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From Vaccination on Day 1 through 4 Weeks after Vaccination
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.
From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.
From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.
From Vaccination on Day 1 through 6 Months after Vaccination
Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority
GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
At 4 Weeks after Vaccination
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority
Seroconversion was defined as having an HAI titer \<1:10 prior to vaccination and greater than or equal to (\>=) 1:40 at the postvaccination time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
At 4 Weeks after Vaccination
Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.
At 4 Weeks after Vaccination
Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority
Seroresponse was defined as achieving a postvaccination \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>=4\*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section.
At 4 Weeks after Vaccination
Secondary Outcomes (2)
Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination
Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority
At 4 Weeks after Vaccination
Study Arms (8)
Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
EXPERIMENTALCohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
ACTIVE COMPARATORCohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
EXPERIMENTALCohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
ACTIVE COMPARATORCohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 3 Arm E:Influenza and COVID-19 Combination B
EXPERIMENTALCohort 3 Arm E:Influenza and COVID-19 Combination B
Cohort 3 Arm F: COVID-19 vaccine
ACTIVE COMPARATORCohort 3 Arm F: COVID-19 vaccine
Cohort 3 Arm G: Licensed influenza vaccine
ACTIVE COMPARATORCohort 3 Arm G: Licensed influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccine
ACTIVE COMPARATORCohort 3 Arm H: Investigational influenza vaccine
Interventions
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
Licensed influenza vaccine
Pfizer-BioNTech COVID-19 vaccine
Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Saline Solution
Investigational influenza vaccine
Eligibility Criteria
You may qualify if:
- Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Pfizercollaborator
Study Sites (106)
North Alabama Research Center
Athens, Alabama, 35611, United States
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216, United States
AMR Clinical
Mobile, Alabama, 36608, United States
HOPE Research Institute
Phoenix, Arizona, 85032, United States
Foothills Research Center/ CCT Research
Phoenix, Arizona, 85044, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281, United States
Baptist Health Center For Clinical Research
Little Rock, Arkansas, 72205, United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Ascada Health PC dba Ascada Research
Fullerton, California, 92835, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
Bayview Research Group, LLC
Valley Village, California, 91607, United States
Synexus Clinical Research US, Inc.
Vista, California, 92083, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Universal Axon Clinical Research, LLC
Doral, Florida, 33166, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Best Quality Research,Inc.
Hialeah, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Gerardo Polanco, MD
Miami, Florida, 33156, United States
Research Institute of South Florida
Miami, Florida, 33173, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Clinical Site Partners LLC, dba Flourish Research
Miami, Florida, 33186, United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014, United States
Angels Clinical Research Institute
Miami Lakes, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
Angels Clinical Research Institute
Tampa, Florida, 33614, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, 31904, United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, 30328, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Koch Family Medicine
Morton, Illinois, 61550, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106, United States
AMR Clinical
Wichita, Kansas, 67207, United States
Pharmaron
Baltimore, Maryland, 21201, United States
Jadestone Clinical Research
Silver Spring, Maryland, 20904, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Revival Research Institute, LLC
Sterling Heights, Michigan, 48312, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114, United States
Saint Louis University Center for Vaccine Development
St Louis, Missouri, 63104, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134, United States
McGill Family Practice
Papillion, Nebraska, 68046, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
Accellacare - Hickory
Hickory, North Carolina, 28601, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Accellacare - Rocky Mount
Rocky Mount, North Carolina, 27804, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219, United States
Synexus Clinical Research US, Inc.
Cincinnati, Ohio, 45236, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Trial Management Associates, LLC
Myrtle Beach, South Carolina, 29572, United States
Trial Management Associates
Myrtle Beach, South Carolina, 29572, United States
Internal Medicine and Pediatric Associates of Bristol
Bristol, Tennessee, 37620, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
Benchmark Research
Austin, Texas, 78705, United States
Tekton Research, LLC.
Austin, Texas, 78745, United States
Orion Clinical Research
Austin, Texas, 78759, United States
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526, United States
DFW Clinical Research
Dallas, Texas, 75240, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Texas Health Family Care
Fort Worth, Texas, 76135, United States
Santa Clara Family Clinic
Houston, Texas, 77087, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
ACRC Trials (Administrative Location)
Plano, Texas, 75024, United States
ACRC TRIALS / North Texas Family Medicine
Plano, Texas, 75093, United States
AIM Trials, LLC
Plano, Texas, 75093, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
DM Clinical Research, Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
AMR Clinical
Layton, Utah, 84041, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
AMR Clinical
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BioNTech clinical trials patient information
- Organization
- BioNTech SE
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2023
First Posted
December 21, 2023
Study Start
December 20, 2023
Primary Completion
November 26, 2024
Study Completion
November 26, 2024
Last Updated
December 4, 2025
Results First Posted
December 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share