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

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: COVID-19; Influenza,Human
• Intervention / Treatment: Other: Placebo; Biological: COVID-19 Vaccine; Biological: Investigational Influenza Vaccine; Biological: Licensed Influenza Vaccine 1; Biological: Licensed Influenza Vaccine 2; Combination product: Influenza and COVID Combination Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1353
• Phase: Phase 2; Phase 1

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; COVID-19 Vaccine (Dose 1) and Placebo	Other: Placebo; Saline; Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm B; COVID-19 Vaccine (Dose 2) and Placebo	Other: Placebo; Saline; Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Active Comparator: Arm C; COVID-19 Vaccine (Dose 3) and Placebo	Other: Placebo; Saline; Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm D; Investigational Influenza Vaccine (Dose 1) and Placebo	Other: Placebo; Saline; Biological: Investigational Influenza Vaccine; Investigational Influenza Vaccine
Active Comparator: Arm E; Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)	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 COVID-19 Vaccine (Dose 3)	Biological: COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine; Biological: Licensed Influenza Vaccine 2; Licensed Influenza Vaccine 2
Experimental: Arm F; Investigational Influenza Vaccine (Dose 2) and Placebo	Other: Placebo; Saline; Biological: Investigational Influenza Vaccine; Investigational Influenza Vaccine
Experimental: Arm G; Influenza and COVID Combination Vaccine (Combination 1) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm H; Influenza and COVID Combination Vaccine (Combination 2) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm I; Influenza and COVID Combination Vaccine (Combination 3) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm J; Investigational Influenza Vaccine (Dose 3) and Placebo	Other: Placebo; Saline; Biological: Investigational Influenza Vaccine; Investigational Influenza Vaccine
Experimental: Arm K; Influenza and COVID Combination Vaccine (Combination 4) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm L; Influenza and COVID Combination Vaccine (Combination 5) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm M; Influenza and COVID Combination Vaccine (Combination 6) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Experimental: Arm N; Influenza and COVID Combination Vaccine (Combination 7) and Placebo	Other: Placebo; Saline; Combination product: Influenza and COVID Combination Vaccine; Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration	Describe prompted systemic events following investigational product administration	Day 7
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration	Describe AEs occurring through 4 weeks following administration of investigational product	4 weeks after vaccination
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration	Describe SAEs through 6 months following administration of investigational product	6 months after vaccination
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration	Describe prompted local reactions following investigational product administration	Day 7

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): 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 (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 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; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: C5261023

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