A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Combined With Aluminum Hydroxide Adjuvant in Children, Toddlers, and Infants

Trial Profile

A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Combined With Aluminum Hydroxide Adjuvant in Children, Toddlers, and Infants

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs TAK 214 (Primary) ; Aluminium hydroxide; Monophosphoryl lipid A
  • Indications Norovirus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Takeda
  • Most Recent Events

    • 27 Jul 2017 Planned End Date changed from 23 Mar 2018 to 15 Nov 2018.
    • 27 Jul 2017 Planned primary completion date changed from 1 Mar 2018 to 15 Nov 2018.
    • 27 Jul 2017 Status changed from recruiting to active, no longer recruiting.
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