CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10,000 enrolled
Drug / intervention
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine +1 morebiological
Likely dose
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus 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/NCT01981967
NCT01981967Phase 4Completed
CompareCT.gov

Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 13, 2013·Updated May 4, 2016

In Brief

A Phase 4 clinical trial evaluating IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine for Japanese Encephalitis. Completed, enrolled 10,000 participants across 8 sites.

Detailed Summary

The aim of this study is to further characterize the safety profile of IMOJEV®. Primary Objective: * To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®. Secondary Objective: * To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartNov 1, 2013
Primary CompletionApr 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.6 years ago

Interventions

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccinebiological

0.5 mL, Subcutaneous.

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccinebiological

0.5 mL, Subcutaneous.