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 ]

calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)


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