CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 389 enrolled
Drug / intervention
Japanese Encephalitis purified inactivated vaccinebiological
Likely dose
Japanese Encephalitis purified inactivated vaccine 6 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00595465
NCT00595465Phase 3Completed

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

Valneva Austria GmbH·interventional·Posted Jan 16, 2008·Updated May 16, 2014

In Brief

A Phase 3 clinical trial evaluating Japanese Encephalitis purified inactivated vaccine for Japanese Encephalitis. Completed, enrolled 389 participants across 4 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2008
Enrollment StartDec 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.5 years ago

Interventions

Japanese Encephalitis purified inactivated vaccinebiological

IC51 6 mcg i.m. injection on Day 0 and Day 28