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

Trial status:Recruiting
Trial ID:
C6271001
NCT ID:
NCT06821061
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

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.

Medical Condition
  • Influenza
  • COVID-19
    • Trial Drug
  • Investigational Influenza Vaccine
    • See more
  • Investigational COVID-19 Vaccine
  • Licensed Influenza Vaccine 1
  • Licensed Influenza Vaccine 2
  • Licensed Influenza Vaccine 3
  • Licensed COVID-19 Vaccine
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    2645
    Estimated Trial Date
    Feb 2025 - Dec 2025

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion criteria

      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

    Trial Locations

    Location
    Status
    Location
    Anaheim Clinical Trials, LLC
    Anaheim, California, United States, 92801
    Status
    Recruiting
    Location
    Orange County Research Center
    Lake Forest, California, United States, 92630
    Status
    Recruiting
    Location
    Artemis Institute for Clinical Research
    Riverside, California, United States, 92503
    Status
    Recruiting
    Location
    Artemis Institute for Clinical Research
    San Diego, California, United States, 92103
    Status
    Recruiting
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Recruiting
    Location
    Clinical Research Consulting
    Milford, Connecticut, United States, 06460
    Status
    Recruiting
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