Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2013-03
- Completion
- 2013-06
Outcome
Met primary endpoint
paper The primary endpoint of non-inferiority of seroconversion rates on D28 was demonstrated in the Per Protocol analysis set PMID 25483480 ↗
paper difference between Group JE-CV and Group SA14-14-2 was 0.9 percentage points (95% confidence interval [CI]: -2.35; 4.68), which was above the required -10%. PMID 25483480 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CD.JEVAX™ | Unknown | 0.5 ml | Subcutaneous |
| Subject | IMOJEV | Vaccine | 0.5 ml | Subcutaneous |