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A phase 3 booster vaccination trial to evaluate the immunogenicity and safety of a booster vaccination with DS-5670 (bivalent, the original strain and omicron BA.4-5 subvariant) in individuals who were aged 12 years or older and had completed the primary and booster series of SARS- CoV-2 vaccines

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Trial Profile

A phase 3 booster vaccination trial to evaluate the immunogenicity and safety of a booster vaccination with DS-5670 (bivalent, the original strain and omicron BA.4-5 subvariant) in individuals who were aged 12 years or older and had completed the primary and booster series of SARS- CoV-2 vaccines

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2024

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At a glance

  • Drugs DS 5670 (Primary)
  • Indications COVID 2019 infections
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Daiichi Sankyo Company

Most Recent Events

  • 31 Jul 2024 According to a Daiichi Sankyo media release, in n June 2024, the application for approval was accepted in Japan for administration of DS-5670 to ages 12 years and older as vaccines against strains selected by the Ministry of Health, Labour and Welfare of Japan (MHLW) for Fiscal 2024 in Japan .
  • 13 Sep 2023 New trial record
  • 07 Sep 2023 According to a Daiichi Sankyo media release, the comapny today announced that it has submitted a supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for an omicron XBB.1.5-adapted mRNA vaccine (DS-5670) against the novel coronavirus infectious disease (COVID-19) for booster vaccination for individuals aged 12 years or older.

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