Clinical Trial: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Brief Summary: The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Detailed Summary:
Sponsor: Valneva Austria GmbH

Current Primary Outcome: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) [ Time Frame: 24 months after the first vaccination ]

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302


Original Primary Outcome:

Current Secondary Outcome:

  • Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) [ Time Frame: 6, 12, 36, 48 and 60 months after 1st vaccination ]
  • Geometric Mean Titers [ Time Frame: 6, 12, 36, 48 and 60 months ]
  • Adverse Events [ Time Frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination ]


Original Secondary Outcome:

Information By: Valneva Austria GmbH

Dates:
Date Received: January 4, 2008
Date Started: October 2005
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014