CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) +3 morebiological
Likely dose
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) 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/NCT02492165
NCT02492165Phase 3Completed

Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 8, 2015·Updated Mar 28, 2022

In Brief

A Phase 3 clinical trial evaluating Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) for Japanese Encephalitis. Completed, enrolled 250 participants across 1 site.

Detailed Summary

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations. Primary objective: \- To describe the safety profile of a single dose of IMOJEV®. Secondary objectives: * To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesVietnam

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 8, 2015
Enrollment StartJun 1, 2015
Primary CompletionMar 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.0 years ago

Interventions

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)biological

0.5 mL, Subcutaneous

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)biological

0.5 mL, Subcutaneous

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)biological

0.5 mL, Subcutaneous

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)biological

0.5 mL, Subcutaneous