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A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)

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Trial Profile

A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2024

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At a glance

  • Drugs S 268019 (Primary) ; AZD 1222
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors Shionogi

    • Most Recent Events

    • 24 Nov 2022 Primary endpoint has been met. (Booster Vaccination Part; SARS-CoV-2 neutralizing antibody titer at 28 days following the booster vaccination)
    • 24 Nov 2022 Primary endpoint has been met. (Primary Vaccination Part; SARS-CoV-2 neutralizing antibody titer at 28 days following the second vaccination)
    • 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.

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