CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
IMOJEVbiological
Likely dose
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/NCT01900444
NCT01900444Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Exploration of a Booster Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given One Year After Primary Immunization in Healthy Children in South Korea

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 16, 2013·Updated Mar 28, 2022

In Brief

A Phase 3 clinical trial evaluating IMOJEV for Japanese Encephalitis. Completed, enrolled 119 participants across 8 sites.

Detailed Summary

The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: * To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV. Exploratory objectives: * To describe the safety profile of a booster dose of IMOJEV® .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 16, 2013
Enrollment StartJul 11, 2013
Primary CompletionMar 11, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.0 years ago

Interventions

IMOJEVbiological

0.5 mL, Subcutaneous