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