Clinical Trial: Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
Brief Summary: The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years
Detailed Summary:
Sponsor: Valneva Austria GmbH
Current Primary Outcome:
- SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 [ Time Frame: Day 56 ]SCR: anti-JEV neutralizing antibody titer ≥1:10
- GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 [ Time Frame: Day 56 ]GMT: geometric mean of PRNT50
Original Primary Outcome: Immunogenicity of IC51 compared to JE-VAX 4 weeks after the last vaccination
Current Secondary Outcome:
- Safety and Adverse Events [ Time Frame: until Day 56 ]
- Immunogenicity at Day 28 [ Time Frame: Day 28 ]
- Immunogenicity at Day 56 for North America vs. Europe [ Time Frame: Day 56 ]
- Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age [ Time Frame: Day 56 ]
Original Secondary Outcome: Safety and Adverse Events
Information By: Valneva Austria GmbH
Dates:
Date Received: January 4, 2008
Date Started: September 2005
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016