NCT00595465

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Japanese Encephalitis purified inactivated vaccine	IC51 6 mcg i.m. injection on Day 0 and Day 28

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-02-01
• Completion: 2008-06-01
• First posted: 2008-01-16
• Last updated: 2014-05-16
• Results posted: 2012-11-20

Locations

4 sites across 2 countries: Austria, Germany