CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 867 enrolled
Drug / intervention
IC51 +1 morebiological
Likely dose
IC51 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/NCT00604708
NCT00604708Phase 3Completed

Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Valneva Austria GmbH·interventional·Posted Jan 30, 2008·Updated Mar 21, 2024

In Brief

A Phase 3 clinical trial evaluating IC51 and JE-VAX for Japanese Encephalitis. Completed, enrolled 867 participants.

Detailed Summary

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged \> or = 18 years

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.4 years ago

Interventions

IC51biological

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

JE-VAXbiological

JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28