At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea
In Brief
A Phase 3 clinical trial evaluating Live attenuated Japanese encephalitis chimeric virus vaccine and Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine) for Japanese Encephalitis and Japanese Encephalitis Virus Disease. Completed, enrolled 274 participants across 6 sites.
Detailed Summary
The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \[CD.JEVAX™\]) after a single dose vaccination to support product registration. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine. Secondary Objectives: * To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine. * To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.
Study Details
Timeline
Interventions
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous