Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

Trial status:Study Complete
Study Identifier:
C4591030
ClinicalTrials.gov Identifier:
NCT05310084
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

Results available

Study Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Trial details

Medical Condition
  • COVID-19
    • Study Drug
  • Biological: BNT162b2
  • Biological: Seasonal Inactivated Influenza Vaccine
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 64 Years
    Estimated Trial Date
    Apr 2022 - Oct 2022

    Protocol summary

    This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). * Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group * The duration of the study for each participant will be approximately 2 months * There are 3 scheduled study visits each about 1 month apart * The study will be conducted in New Zealand and Australia.

    Trial locations

    Location
    Status
    Location
    Northern Beaches Clinical Research
    Brookvale, New South Wales, Australia, 2100
    Status
    Location
    Australian Clinical Research Network
    Sydney, New South Wales, Australia, NSW 2035
    Status
    Location
    Westmead Hospital
    Westmead, New South Wales, Australia, 2145
    Status
    Location
    Paratus Clinical Research Brisbane
    Albion, Queensland, Australia, 4010
    Status
    Location
    AusTrials - Wellers Hill
    Wellers Hill, Queensland, Australia, 4121
    Status
    Location
    Emeritus Research
    Camberwell, Victoria, Australia, 3124
    Status