Clinical Trial: Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis

Brief Summary: The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

Detailed Summary:

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.


Sponsor: Valneva Austria GmbH

Current Primary Outcome: SCR (Seroconversion Rate) at Day 56 [ Time Frame: day 56 ]

Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer


Original Primary Outcome: Immunogenicity of the rapid immunization regime compared to the standard regime of IC51 2 months after the first vaccination

Current Secondary Outcome:

  • SCR at Day 10, 28 and 35 [ Time Frame: Day 10, 28 and 35 ]
  • GMT at Day 10, 28, 35 and 56 [ Time Frame: Day 10, 28, 35 and 56 ]
  • Safety [ Time Frame: Study duration ]
    AEs, Local and systemic tolerability, Safety laboratory parameters


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: April 9, 2014
Last Verified: April 2014