drugset / Trial / NCT01188343

Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers

NCT01188343 ↗

Phase 3 Completed 542 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months. Primary objective: * To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine. Secondary objectives: * To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively. * To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.

Timeline

Start
2010-08
Primary completion
2012-07
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Japanese encephalitis chimeric virus Vaccine 0.5 ml Subcutaneous
Subject Measles, mumps, and rubella live attenuated virus Vaccine 0.5 ml Subcutaneous