CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,200 enrolled
Drug / intervention
Japanese encephalitis vaccine +4 morebiological
Likely dose
Japanese encephalitis vaccine 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/NCT00735644
NCT00735644Phase 3Completed
CompareCT.gov

Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 15, 2008·Updated Apr 21, 2015

In Brief

A Phase 3 clinical trial evaluating Japanese encephalitis vaccine, Japanese encephalitis vaccine (Acambis), and 1 other intervention for Japanese Encephalitis and Hepatitis A. Completed, enrolled 1,200 participants across 8 sites in 2 countries.

Detailed Summary

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis, Hepatitis A
CountriesPhilippines, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2008
Enrollment StartAug 1, 2008
Primary CompletionMay 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.9 years ago

Interventions

Japanese encephalitis vaccinebiological

0.5 mL, Subcutaneous

Japanese encephalitis vaccinebiological

0.5 mL, Subcutaneous

Japanese encephalitis vaccinebiological

0.5 mL, Subcutaneous

Japanese encephalitis vaccine (Acambis)biological

0.5 mL, Subcutaneous

Hepatitis A vaccinebiological

0.5 mL, Intramuscular