Japanese Encephalitis Clinical Trial
Official title:
A Controlled Study of the Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Comparison With SA14-14-2 Vaccine in Infants and Toddlers in Thailand
The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric
virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in
infants and toddlers.
Primary Objective:
- To demonstrate the non-inferiority of the antibody response 28 days after vaccine
administration of one dose of JE CV (administered on Day 0) compared to the antibody
response after one dose of the SA14-14-2 control vaccine (administered on Day 0).
Secondary Objectives:
- To describe the immune response to JE in both vaccine groups in JE-CV virus and
SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2
vaccine
- To describe the safety profile in all vaccinated subjects up to 28 days and all serious
adverse events (SAEs) up to 6 months after vaccination.
- To describe only related SAEs and all death from 6 month to 12-month follow-up.
All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after 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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