A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

Trial status:Recruitment Complete
Study Identifier:
C5261002
ClinicalTrials.gov Identifier:
NCT06178991
EudraCT Identifier:
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
Recruitment Complete

Trial details

Medical Condition
  • Influenza
  • COVID-19
    • Study Drug
  • Biological: Influenza and COVID-19 Combination A
  • Biological: Licensed influenza vaccine
  • Biological: COVID-19 Vaccine
    • See more
  • Biological: Influenza and COVID-19 Combination B
  • Biological: Placebo
  • Biological: Investigational influenza vaccine
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 64 Years
    Estimated Trial Date
    Dec 2023 - Nov 2024

    Protocol summary

    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.

    Trial locations

    Location
    Status
    Location
    North Alabama Research Center
    Athens, Alabama, United States, 35611
    Status
    Location
    Accel Research Sites Network - Birmingham Clinical Research Unit
    Birmingham, Alabama, United States, 35216
    Status
    Location
    Medical Affiliated Research Center
    Huntsville, Alabama, United States, 35801
    Status
    Location
    Alliance for Multispecialty Research, LLC
    Mobile, Alabama, United States, 36608
    Status
    Location
    Hope Research Institute
    Phoenix, Arizona, United States, 85018
    Status
    Location
    The Pain Center of Arizona
    Phoenix, Arizona, United States, 85018
    Status