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

Trial status:Study Complete
Study Identifier:
C5261001
ClinicalTrials.gov Identifier:
NCT05596734
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
Study Complete

Trial details

Medical Condition
  • Influenza
  • COVID-19
    • Study Drug
  • Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5)
  • Biological: qIRV (22/23)
  • Biological: QIV
    • See more
  • Biological: bIRV
  • Biological: tIRV
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+
    Estimated Trial Date
    Oct 2022 - Dec 2023

    Protocol summary

    Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: * qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations * qIRV (22/23) at dose level 1, * qIRV (22/23) at dose level 2, or * bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).

    Trial locations

    Location
    Status
    Location
    North Alabama Research Center
    Athens, Alabama, United States, 35611
    Status
    Location
    The Heart Center
    Athens, Alabama, United States, 35611
    Status
    Location
    HOPE Research Institute
    Phoenix, Arizona, United States, 85018
    Status
    Location
    The Pain Center of Arizona
    Phoenix, Arizona, United States, 85018
    Status
    Location
    Orange County Research Center
    Lake Forest, California, United States, 92630
    Status
    Location
    Orange County Heart Institute
    Orange, California, United States, 92868
    Status