A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

Trial status:Study Complete
Study Identifier:
C4591017
ClinicalTrials.gov Identifier:
NCT04713553
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: BNT162b2.B.1.351
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12 - 50 Years
    Estimated Trial Date
    Feb 2021 - Jul 2021

    Protocol summary

    This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): * As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) * As a 20-microgram dose, administered from 1 of the manufacturing lots * As a 2-dose (separated by 21 days) schedule * In people 12 through 50 years of age The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351): * Each as a 30-microgram dose * Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2 * In people 18 through 50 years of age

    Trial locations

    Location
    Status
    Location
    Kaiser Permanente Oakland
    Oakland, California, United States, 94611
    Status
    Location
    Clinical Research Consulting
    Milford, Connecticut, United States, 06460
    Status
    Location
    Indago Research & Health Center, Inc
    Hialeah, Florida, United States, 33012
    Status
    Location
    Research Centers of America
    Hollywood, Florida, United States, 33024
    Status
    Location
    Clinical Neuroscience Solutions
    Orlando, Florida, United States, 32801
    Status
    Location
    Clinical Research Atlanta
    Stockbridge, Georgia, United States, 30281
    Status