Clinical Trial: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.
Brief Summary: The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
Detailed Summary:
Sponsor: Valneva Austria GmbH
Current Primary Outcome: Seroconversion Rate [ Time Frame: at Month 12 after booster ]
Original Primary Outcome: Seroconversion Rate
Current Secondary Outcome:
- Safety and Adverse Events [ Time Frame: up to Month 12 after booster ]
- Seroconversion [ Time Frame: at D28 and Month 6 after booster ]
- Geometric Mean Titer [ Time Frame: D28, Month 6 and Month 12 after booster ]
Original Secondary Outcome: Safety and Adverse Events
Information By: Valneva Austria GmbH
Dates:
Date Received: January 4, 2008
Date Started: December 2007
Date Completion:
Last Updated: May 5, 2014
Last Verified: May 2014