At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.
In Brief
A Phase 3 clinical trial evaluating Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus for Japanese Encephalitis and 3 related conditions. Completed, enrolled 542 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL each; Subcutaneous (SC)
0.5 mL each, Subcutaneous (SC)
0.5 mL each, subcutaneous (SC)