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Phase II, Randomized, Placebo-controlled, Double-blind, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in Healthy Adults

Trial Profile

Phase II, Randomized, Placebo-controlled, Double-blind, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in Healthy Adults

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Apr 2019

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At a glance

  • Drugs TAK 214 (Primary)
  • Indications Norovirus infections
  • Focus Adverse reactions
  • Sponsors Takeda
  • Most Recent Events

    • 18 Apr 2019 Results evaluating the long-term safety and immunogenicity six and twelve months after initial vaccination published in the Journal of Infectious Diseases
    • 28 Jun 2016 Results published in the Journal of Infectious Diseases
    • 12 May 2016 No of arms changed from 5 to 3. Also from primary end points, cohort 1 and cohort 2 separation and time frame for the cohort 2 is removed
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