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A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity of a Booster Dose of S-268019 or COMIRNATY (COVID-19)

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Trial Profile

A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity of a Booster Dose of S-268019 or COMIRNATY (COVID-19)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 14 Oct 2024

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At a glance

  • Drugs S 268019 (Primary) ; Tozinameran
  • Indications COVID 2019 infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Shionogi

Most Recent Events

  • 24 Jun 2024 According to Shionogi media release, the company has obtained domestic manufacturing and sales approval for COVGOZE, a single-strain preventive vaccine against COVID-19, listing "prevention of infection caused by SARS-CoV-2" as its efficacy and effects for initial immunization.
  • 24 Nov 2022 According to Shionogi media release, company announced that it has filed for manufacturing and sales approval of S-268019, a recombinant protein-based preventive vaccine, for use in priming and booster (3rd) doses, against COVID-19, caused by the novel coronavirus (SA-CoV-2) infection, The filing is based on the positive results of five clinical trials (jRCT2031210383, jRCT2031210269, jRCT2031210470, jRCT2031210613 and jRCT2051210151) conducted in Japan.
  • 24 Nov 2022 Primary endpoint (neutralizing antibody titer against SARS-CoV-2 28 days after the additional dose) has been met, according to Shionogi media release.

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