Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

Trial status:Study Complete
Trial ID:
C4591005
NCT ID:
NCT04588480
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 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

  • As 2 doses, separated by 21 days
  • At a single dose level
  • In adults 20 to 85 years of age
Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b2
    • Phase
    Phase 4
    Type
    Interventional
    Estimated Enrolment
    160
    Estimated Trial Date
    Oct 2020 - Nov 2021

    Trial Participant Requirements

    Age
    20 - 85 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    SOUSEIKAI Sumida Hospital
    Sumida-ku, Tokyo, Japan, 130-0004
    Status
    Location
    SOUSEIKAI PS Clinic
    Fukuoka, Japan, 812-0025
    Status