Clinical Trial: Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in
Brief Summary: To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test
Detailed Summary:
Sponsor: Novartis Vaccines
Current Primary Outcome:
- Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination. [ Time Frame: 7 days ]
- Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination. [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines. [ Time Frame: 8 months ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: November 16, 2007
Date Started: October 2007
Date Completion:
Last Updated: November 30, 2016
Last Verified: February 2012
