A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

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

The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.

This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.

Study Overview

• Status: Completed
• Conditions: Influenza; COVID-19 (Coronavirus Disease 2019)
• Intervention / Treatment: Biological: Investigational Influenza Vaccine; Biological: Licensed Influenza Vaccine 1; Biological: Licensed Influenza Vaccine 2; Biological: Investigational COVID-19 Vaccine; Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Biological: Licensed COVID-19 Vaccine; Biological: Licensed Influenza Vaccine 3

• Study Type: Interventional
• Enrollment (Actual): 2650
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research
    • 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
    • Doral, Florida, United States, 33172
      • Alliance for Multispecialty Research, LLC
    • 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
  • 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
  • Nevada
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Global Health Institute
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates - Wilmington - Floral Parkway
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Centricity Research Columbus Ohio Multispecialty
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • DM Clinical Research - Philadelphia
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • AMR Clinical
    • Knoxville, Tennessee, United States, 37920
      • AMR Clinical
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Brownsville, Texas, United States, 78526
      • Headlands Horizons, LLC dba Headlands Research-Brownsville
    • 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
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente Washington Health Research Institute (KPWHRI)

Participation Criteria

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 judgement of the investigator to be eligible for inclusion in the study

Exclusion criteria:

• Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
• Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
• Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1.

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: Quadruple

Number of Arms

33

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Low Dose COVID-19 Vaccine (1a)	Biological: Investigational COVID-19 Vaccine; Investigational COVID-19 Vaccine
Experimental: Arm B; Low Dose COVID-19 Vaccine ( 1b)	Biological: Investigational COVID-19 Vaccine; Investigational COVID-19 Vaccine
Experimental: Arm C; Low Dose COVID-19 Vaccine ( 1c)	Biological: Investigational COVID-19 Vaccine; Investigational COVID-19 Vaccine
Experimental: Arm D; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm E; Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm F; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm G; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator: Arm I; Licensed Influenza Vaccine (1)	Biological: Licensed Influenza Vaccine 1; Licensed Influenza Vaccine 1
Experimental: Arm LL; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator: Arm H; Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm J; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm K; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm L; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator: Arm M; Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Arm N; Licensed Influenza Vaccine (2)	Biological: Licensed Influenza Vaccine 2; Licensed Influenza Vaccine 2
Experimental: Arm AA; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm BB; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm CC; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm DD; Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm EE; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator: Arm FF; Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Arm GG; Licensed Influenza Vaccine (3)	Biological: Licensed Influenza Vaccine 3; Licensed Influenza Vaccine 3
Active Comparator: Arm HH; Licensed Influenza Vaccine (2)	Biological: Licensed Influenza Vaccine 2; Licensed Influenza Vaccine 2
Experimental: Arm II; Low Dose COVID-19 Vaccine ( 1b)	Biological: Investigational COVID-19 Vaccine; Investigational COVID-19 Vaccine
Experimental: Arm JJ; Low Dose COVID-19 Vaccine ( 1c)	Biological: Investigational COVID-19 Vaccine; Investigational COVID-19 Vaccine
Experimental: Arm KK; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm MM; Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm NN; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm OO; Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)	Combination product: Investigational Influenza and COVID-19 Combination Vaccine; Investigational Combined Influenza and COVID-19 Vaccine
Experimental: Arm PP; Medium Dose Investigational Influenza Vaccine (1)	Biological: Investigational Influenza Vaccine; Investigational Influenza Vaccine
Experimental: Arm QQ; High Dose Investigational Influenza Vaccine (2)	Biological: Investigational Influenza Vaccine; Investigational Influenza Vaccine
Active Comparator: Arm RR; Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Arm SS; Licensed Influenza Vaccine (3)	Biological: Licensed Influenza Vaccine 3; Licensed Influenza Vaccine 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration	Day 7
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration	Day 7
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration	1 month
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
GMTs before and through 1 month following investigational product administration	Before vaccination through to 1 month 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): February 10, 2025
• Primary Completion (Actual): December 17, 2025
• Study Completion (Actual): December 17, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

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; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: C6271001; C6271001-C1 (Other Identifier: Alias Study Number); C6271001-C1A (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