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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
Download document(s)
Statistical Analysis Plan
Available Languages: English
Download document(s)

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
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    • Japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization.
    • Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
    • Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
    • Capable of giving personal signed informed consent.
    • Exclusion Criteria:

    • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
    • Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
    • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
    • Receipt of medications intended to prevent COVID-19.
    • Previous confirmed diagnosis of COVID-19.
    • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
    • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    • Women who are pregnant or breastfeeding.
    • Previous vaccination with any coronavirus vaccine.
    • Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
    • Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
    • Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
    • Previous participation in other studies involving study intervention containing lipid nanoparticles.
    • Subset only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
    • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

    Trial Locations

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