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
Trial ID:
C4591017
NCT ID:
NCT04713553
EudraCT ID:
N/A
EU Trial (CTIS) Number:
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 Languages: English
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Statistical Analysis Plan
Available Languages: English
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Trial Details

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
Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b2
    • See more
  • BNT162b2.B.1.351
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    1574
    Estimated Trial Date
    Feb 2021 - Jul 2021

    Trial Participant Requirements

    Age
    12 - 50 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    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
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