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A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine

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A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 14 Oct 2024

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At a glance

  • Drugs DS 5670 (Primary)
  • Indications COVID 2019 infections; SARS-CoV-2 acute respiratory disease
  • Focus Pharmacodynamics; Registrational
  • Sponsors Daiichi Sankyo Company

    • Most Recent Events

    • 19 May 2023 According to a Daiichi Sankyo Company media release, first patient has been dosed in phase 3 of this study.
    • 13 Jan 2023 According to a Daiichi Sankyo Company media release, based on the data of this study, the company has submitted the application for marketing approval of DS-5670 to the regulatory authorities in Japan.
    • 15 Nov 2022 According to a Daiichi Sankyo Company media release, based on the trial results, Daiichi Sankyo will proceed with preparation for a new drug application of the mRNA vaccine in January 2023.

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