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A Randomised, Double-blind, Placebo-controlled, Single-centre Phase IIb Trial as Part of the EU-funded UNISEC Project to Assess the Immunogenicity and Safety of Different Formulations and Dosing Regimens of FLU-v Vaccine in Healthy Adults

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Trial Profile

A Randomised, Double-blind, Placebo-controlled, Single-centre Phase IIb Trial as Part of the EU-funded UNISEC Project to Assess the Immunogenicity and Safety of Different Formulations and Dosing Regimens of FLU-v Vaccine in Healthy Adults

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Apr 2022

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At a glance

  • Drugs FLU-v (Primary) ; Montanide ISA-51
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors SEEK

    • Most Recent Events

    • 10 Mar 2020 Primary endpoint has been met. (Percentage of Responders on Day 42 and Day 180 for IFNgamma Secretion by PBMCs)
    • 10 Mar 2020 Primary endpoint has been met. (Percentage of CD4+ TH1 Cytokine Responders)
    • 10 Mar 2020 Results published in the Annals of Internal Medicine
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