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Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years

Trial Profile

Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jun 2021

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At a glance

  • Drugs HIL 214 (Primary)
  • Indications Norovirus infections
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Takeda

Most Recent Events

  • 30 Aug 2020 Primary endpoint (Percentage of Participants with Moderate or Severe Acute Gastroenteritis (AGE) Occur0ring 7 Days After Dosing Due to GI.1 or GII.4 NoV Strains (excluding Co-infection)) has not been met as per results published in the Vaccine
  • 30 Aug 2020 Results published in the Vaccine
  • 19 Jun 2018 Status changed from active, no longer recruiting to completed.

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