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Clinical Trial Summary

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.


Clinical Trial Description

All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01092507
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date March 2010
Completion date October 2011

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