Clinical Trial: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Brief Summary: The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
Detailed Summary:
Sponsor: Valneva Austria GmbH
Current Primary Outcome: Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody [ Time Frame: Day 56 ]
Original Primary Outcome: Geometric mean titer
Current Secondary Outcome:
- Seroconversion Rate [ Time Frame: Day 56 ]
- Safety and Adverse Events [ Time Frame: Day 56 ]
Original Secondary Outcome:
- Seroconversion Rate
- 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
