A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

August 17, 2026 updated by: BioNTech SE

A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS

This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1353

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lake Forest, California, United States, 92630
        • Orange County Research Center
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting
    • Florida
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute, LLC
      • Miami Lakes, Florida, United States, 33014
        • Palm Springs Community Health Center
      • Orlando, Florida, United States, 32819
        • Headlands Research Orlando
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Springfield, Missouri, United States, 65802
        • Bio-Kinetic Clinical Applications, LLC dba QPS-MO
      • Springfield, Missouri, United States, 65807
        • Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research, Omaha
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices & Research, LLC.
    • Texas
      • Houston, Texas, United States, 77065
        • DM Clinical Research- Cyfair
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research
      • Tomball, Texas, United States, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants 18 years of age or older
  • Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria:

  • Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine.
  • Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1

Please refer to the study contact for further eligibility details.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
Other: Placebo
Saline
Biological: Investigational Influenza Vaccine
Investigational Influenza Vaccine
Active Comparator: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Biological: Licensed Influenza Vaccine 1
Licensed Influenza Vaccine 1
Active Comparator: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Biological: Licensed Influenza Vaccine 2
Licensed Influenza Vaccine 2
Experimental: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
Other: Placebo
Saline
Biological: Investigational Influenza Vaccine
Investigational Influenza Vaccine
Experimental: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
Other: Placebo
Saline
Biological: Investigational Influenza Vaccine
Investigational Influenza Vaccine
Experimental: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
Other: Placebo
Saline
Combination product: Investigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 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
Time Frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
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
Time Frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
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
Time Frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the 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
Time Frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the 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 1 Month After Vaccination
Time Frame: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
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 1 month after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
Time Frame: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
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 1 month after Vaccination [Vaccination on Day 1]
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Time Frame: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
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. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Time Frame: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
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. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNTech SE

Collaborators

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5261023
  • C5261023-C1; C5261023-C2 (Other Identifier: Alias Study Number)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe