NCT01188343

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

Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 542 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

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.

Detailed description

All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.

Conditions

• Japanese Encephalitis
• Measles
• Mumps
• Rubella

Interventions

Type	Name	Description
BIOLOGICAL	Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus	0.5 mL each; Subcutaneous (SC)
BIOLOGICAL	Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus	0.5 mL each, Subcutaneous (SC)
BIOLOGICAL	Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus	0.5 mL each, subcutaneous (SC)

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2010-08-25
• Last updated: 2014-08-15
• Results posted: 2014-08-15

Locations

3 sites across 1 country: Taiwan