CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 820 enrolled
Drug / intervention
ChimeriVax™-JE +1 morebiological
Likely dose
ChimeriVax™-JE 0.5 mLfrom 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/NCT00314145
NCT00314145Phase 3Completed

A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)

Sanofi·interventional·Posted Apr 13, 2006·Updated Dec 6, 2012

In Brief

A Phase 3 clinical trial evaluating ChimeriVax™-JE and JE-VAX® for Japanese Encephalitis. Completed, enrolled 820 participants across 10 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2006
Enrollment StartNov 1, 2005
Primary CompletionJun 1, 2006
Study CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 20.2 years ago

Interventions

ChimeriVax™-JEbiological

0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

JE-VAX®biological

0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)