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A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)

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Trial Profile

A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 08 May 2023

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At a glance

  • Drugs Elasomeran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Takeda

    • Most Recent Events

    • 04 Mar 2022 Status changed from active, no longer recruiting to completed.
    • 08 Feb 2022 Interim Results evaluating safety and immunogenicity of mRNA-1273 in healthy Japanese participants, published in the Vaccine
    • 21 May 2021 According to Moderna media release, the Ministry of Health, Labour and Welfare (MHLW) of Japan granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna's mRNA COVID-19 vaccine, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan based on Moderna's Phase 3 COVE study results and positive initial clinical data from the Takeda-led Phase 1/2 study. Distribution by Takeda in Japan will begin immediately
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