Clinical Trial: H5N1 Vaccine Study in Japanese Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healt

Brief Summary: The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.

Detailed Summary:
Sponsor: Nanotherapeutics, Inc.

Current Primary Outcome:

  • Number of subjects with antibody response to the vaccine strain [ Time Frame: 21 days after 2nd vaccination ]
    Measurement by single radial hemolysis (SRH) assay
  • Number of subjects demonstrating seroconversion [ Time Frame: 21 days after 2nd vaccination ]
    Measurement by SRH assay
  • Fold increase of antibody response [ Time Frame: 21 days after 2nd vaccination ]
    Measurement by SRH assay


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of subjects with antibody response to the vaccine strain [ Time Frame: 21 days after 1st and 21+180 days after 2nd vaccination ]
    Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay
  • Number of subjects demonstrating seroconversion [ Time Frame: 21 days after 1st and 21+180 days after 2nd vaccination ]
    Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay
  • Antibody response [ Time Frame: 21 days after 1st and 21 + 180 days after 2nd vaccination ]
    Measurement by SRH, MN and HI assay
  • Fold increase of antibody response [ Time Frame: 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline ]
    Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay


Original Secondary Outcome: Same as current

Information By: Nanotherapeutics, Inc.

Dates:
Date Received: June 24, 2011
Date Started: June 2011
Date Completion:
Last Updated: October 7, 2015
Last Verified: September 2012