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A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms

Trial Profile

A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2019

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At a glance

  • Drugs Baloxavir-marboxil (Primary) ; Oseltamivir
  • Indications Influenza virus infections
  • Focus Adverse reactions; Registrational
  • Acronyms MINISTONE-2
  • Sponsors Genentech; Roche
  • Most Recent Events

    • 02 Sep 2019 According to a Shionogi media release, full results of this study were presented as a late-breaking abstract at OPTIONS X on September 1, 2019.
    • 02 Sep 2019 Results published in the Shionogi Media Release
    • 01 Sep 2019 According to an Genentech Media Release, this study is the fourth positive Phase III study for Xofluza, which has now demonstrated benefit in several populations (otherwise-healthy, high-risk, children) and treatment settings (symptomatic, post-exposure prophylaxis).
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