Clinical Trial: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
Brief Summary: The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years
Detailed Summary:
Sponsor: Valneva Austria GmbH
Current Primary Outcome: Safety and Tolerability up to Day 56 [ Time Frame: Day 56 ]
Original Primary Outcome: Safety and tolerability of IC51 until 4 weeks after the last vaccination
Current Secondary Outcome:
- Rates of Serious Adverse Events and Medically Attended Adverse Events [ Time Frame: until Day 56 ]
- Changes in Laboratory Parameters [ Time Frame: until Day 56 ]
- SCR and GMT of Subjects With Concomitant Vaccinations [ Time Frame: until Day 56 ]
Original Secondary Outcome: Rates of Serious Adverse Events and Medically Attended Adverse Events
Information By: Valneva Austria GmbH
Dates:
Date Received: January 4, 2008
Date Started: October 2005
Date Completion:
Last Updated: October 19, 2012
Last Verified: October 2012