Japanese Encephalitis Clinical Trial
Official title:
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
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.
All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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