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A Phase 1/2, randomized, double-blind, placebo-controlled, parallel-group study of S-268019 in Japanese adult participants

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Trial Profile

A Phase 1/2, randomized, double-blind, placebo-controlled, parallel-group study of S-268019 in Japanese adult participants

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 11 Oct 2024

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At a glance

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

Most Recent Events

  • 16 Dec 2022 Status changed from recruiting to completed, according to results published in the Vaccine.
  • 16 Dec 2022 Interim results published in the Vaccine
  • 16 Dec 2020 According to an Shionogi media release, the trial will be followed up for a year after vaccination. Flash reports from the trial are expected to be obtained sequentially from the end of February 2021. Based on these results, and on the status of the pandemic worldwide, including in Japan, the company will consult with the Ministry of Health, Labor and Welfare, Pharmaceuticals and Medical Devices Agency (PMDA).

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