A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults

Trial Profile

A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults

Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jul 2017

At a glance

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

    • 30 Oct 2016 Results assessing safety and immunogenecity of Norovirus vaccine presented at the IDWeek 2016.
    • 01 Oct 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 27 Aug 2014 New source identified and integrated, European Clinical Trials Database record.
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