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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Influenza
• Intervention / Treatment: Biological: Influenza and COVID-19 Combination A; Biological: Placebo; Biological: Licensed influenza vaccine; Biological: COVID-19 Vaccine; Biological: Influenza and COVID-19 Combination B; Biological: Investigational influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 8795
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center
    • Birmingham, Alabama, United States, 35216
      • Accel Research Sites - Birmingham Clinical Research Unit
    • Mobile, Alabama, United States, 36608
      • AMR Clinical
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • HOPE Research Institute
    • Phoenix, Arizona, United States, 85044
      • Foothills Research Center/ CCT Research
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials
    • Tempe, Arizona, United States, 85281
      • Alliance for Multispecialty Research, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc.
    • Fullerton, California, United States, 92835
      • Ascada Health PC dba Ascada Research
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • Long Beach, California, United States, 90815
      • Ark Clinical Research
    • Los Alamitos, California, United States, 90720
      • Collaborative Neuroscience Research, LLC
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • Valley Village, California, United States, 91607
      • Bayview Research Group, LLC
    • Vista, California, United States, 92083
      • Synexus Clinical Research US, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Doral, Florida, United States, 33166
      • Universal Axon Clinical Research, LLC
    • Fort Lauderdale, Florida, United States, 33308
      • Proactive Clinical Research,LLC
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Hialeah, Florida, United States, 33016
      • Best Quality Research,Inc.
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute, LLC
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami, Florida, United States, 33176
      • Entrust Clinical Research
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida
    • Miami, Florida, United States, 33156
      • Gerardo Polanco, MD
    • Miami, Florida, United States, 33186
      • Clinical Site Partners LLC, dba Flourish Research
    • Miami Lakes, Florida, United States, 33014
      • Palm Springs Community Health Center
    • Miami Lakes, Florida, United States, 33016
      • Angels Clinical Research Institute
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Pembroke Pines, Florida, United States, 33029
      • DBC Research USA
    • Tampa, Florida, United States, 33614
      • Angels Clinical Research Institute
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Centricity Research Columbus Georgia Multispecialty
    • Sandy Springs, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research, Boise
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Synexus Clinical Research US, Inc.
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Ravenswood
    • Morton, Illinois, United States, 61550
      • Koch Family Medicine
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City
  • Kansas
    • Wichita, Kansas, United States, 67207
      • AMR Clinical
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron
    • Silver Spring, Maryland, United States, 20904
      • Jadestone Clinical Research
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Headlands Research - Detroit
    • Sterling Heights, Michigan, United States, 48312
      • Revival Research Institute, LLC
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research
    • St Louis, Missouri, United States, 63104
      • Saint Louis University Center for Vaccine Development
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Velocity Clinical Research, Grand Island
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
    • Papillion, Nebraska, United States, 68046
      • McGill Family Practice
  • Nevada
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New Jersey
    • Warren Township, New Jersey, United States, 07059
      • IMA Clinical Research Warren
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke Vaccine and Trials Unit
    • Hickory, North Carolina, United States, 28601
      • Accellacare - Hickory
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
    • Rocky Mount, North Carolina, United States, 27804
      • Accellacare - Rocky Mount
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates, LLC
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates - Wilmington - Floral Parkway
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45236
      • Synexus Clinical Research US, Inc.
    • Cincinnati, Ohio, United States, 45219
      • Velocity Clinical Research, Cincinnati, Mt. Auburn
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Trial Management Associates
    • Myrtle Beach, South Carolina, United States, 29572
      • Trial Management Associates, LLC
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Internal Medicine and Pediatric Associates of Bristol
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research and Development
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty Research, LLC
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions Inc.
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • Austin, Texas, United States, 78759
      • Orion Clinical Research
    • Austin, Texas, United States, 78745
      • Tekton Research, LLC.
    • Brownsville, Texas, United States, 78526
      • Headlands Horizons, LLC dba Headlands Research-Brownsville
    • Dallas, Texas, United States, 75240
      • DFW Clinical Research
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • Fort Worth, Texas, United States, 76135
      • Texas Health Family Care
    • Houston, Texas, United States, 77087
      • Santa Clara Family Clinic
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • Plano, Texas, United States, 75093
      • AIM Trials, LLC
    • Plano, Texas, United States, 75024
      • ACRC Trials (Administrative Location)
    • Plano, Texas, United States, 75093
      • ACRC TRIALS / North Texas Family Medicine
    • San Antonio, Texas, United States, 78229
      • Ima Clinical Research San Antonio
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC dba Flourish Research
    • Tomball, Texas, United States, 77375
      • Northwest Houston Heart Center
    • Tomball, Texas, United States, 77375
      • DM Clinical Research, Martin Diagnostic Clinic
  • Utah
    • Layton, Utah, United States, 84041
      • AMR Clinical
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc.
    • Norfolk, Virginia, United States, 23502
      • AMR Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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: Placebo; Saline Solution; Biological: Influenza and COVID-19 Combination B; Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Active Comparator: Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group	Biological: Licensed influenza vaccine; Licensed influenza vaccine; Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 vaccine
Active Comparator: Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group	Biological: Licensed influenza vaccine; Licensed influenza vaccine; Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 vaccine
Experimental: Cohort 3 Arm E:Influenza and COVID-19 Combination B	Biological: Influenza and COVID-19 Combination B; Combined influenza and Pfizer-BioNTech COVID-19 vaccine
Active Comparator: Cohort 3 Arm F: COVID-19 vaccine	Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 vaccine
Active Comparator: Cohort 3 Arm G: Licensed influenza vaccine	Biological: Licensed influenza vaccine; Licensed influenza vaccine
Active Comparator: Cohort 3 Arm H: Investigational influenza vaccine	Biological: Investigational influenza vaccine; Investigational influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 3: GMT and GMR of Strain-Specific HAI 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. Data was reported for reported for following strains: H1N1, H3N2 and Victoria.	At 4 Weeks after Vaccination
Cohort 3: GMT and GMR of 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

Collaborators and Investigators

• Sponsor: BioNTech SE
• Collaborators: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): November 26, 2024
• Study Completion (Actual): November 26, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Influenza, Human; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Influenza Vaccines; COVID-19 Vaccines
• Other Study ID Numbers: C5261002; NCT06178991 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No