A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

Trial status:Study Complete
Study Identifier:
C4591020
ClinicalTrials.gov Identifier:
NCT04816669
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
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 55 Years
    Estimated Trial Date
    Apr 2021 - Dec 2021

    Protocol summary

    This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. * 2-dose schedule (separated by 21 days) * At a dose of 30µg (as studied in the Phase 2/3 study C4591001) * In healthy adults 18 through 55 years of age * The duration of the study for each participant will be approximately 2 months (3 visits in total) * The study will be conducted in the United States

    Trial locations

    Location
    Status
    Location
    Anaheim Clinical Trials, LLC
    Anaheim, California, United States, 92801
    Status
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Location
    Indago Research & Health Center, Inc
    Hialeah, Florida, United States, 33012
    Status
    Location
    Research Centers of America ( Hollywood )
    Hollywood, Florida, United States, 33024
    Status
    Location
    Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    Jacksonville, Florida, United States, 32256
    Status
    Location
    Clinical Neuroscience Solutions
    Orlando, Florida, United States, 32801
    Status