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A multicenter, double-blind, randomized, placebo-controlled, parallel-group phase III study for validation of vaccine efficacy of KD-414 (XBB.1.5) in healthy children aged 6 months to less than 13 years

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A multicenter, double-blind, randomized, placebo-controlled, parallel-group phase III study for validation of vaccine efficacy of KD-414 (XBB.1.5) in healthy children aged 6 months to less than 13 years

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2023

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At a glance

  • Drugs KD 414 (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use

    • Most Recent Events

    • 23 Oct 2023 New trial record
    • 16 Oct 2023 According to Meiji Holdings media release, the development of KD-414, including the abovementioned clinical trial, is partially funded by the Ministry of Health, Labour and Welfare of Japan (MHLW) and by the Japan Agency for Medical Research and Development (AMED).
    • 13 Oct 2023 According to Meiji Holdings media release, KM Biologics Co., Ltd. and Meiji Seika Pharma Co., Ltd. submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA)for this trial; After the examination of the clinical trial notification by PMDA and the review by the Institutional Review Board of the medical institution implementing the clinical trial, company will start enrolling subjects and vaccine administration from December 2023

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