At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 50 enrolled

Drug / intervention

Live attenuated chimeric Japanese Encephalitis vaccine +1 morebiological

Likely dose

Live attenuated chimeric 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/NCT02526550

NCT02526550Phase 4Completed

Compare CT.gov

Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children

Siriraj Hospital·interventional·Posted Aug 18, 2015·Updated Dec 7, 2016

In Brief

A Phase 4 clinical trial evaluating Live attenuated chimeric Japanese Encephalitis vaccine and Inactivated Hepatitis A vaccine for Encephalitis. Completed, enrolled 50 participants.

Detailed Summary

This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to \<5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEncephalitis

Countries--

CollaboratorsSanofi Pasteur, a Sanofi Company

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJun 2014

Primary CompletionJul 2014

First PostedAug 2015

TodayJul 2026

First PostedAug 18, 2015

Enrollment StartJun 1, 2014

Primary CompletionJul 1, 2014

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 10.9 years ago

Interventions

Live attenuated chimeric Japanese Encephalitis vaccinebiological

0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh

Inactivated Hepatitis A vaccinebiological

0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh