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Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

Phase 3

Japanese Encephalitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Aug 15, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment542

FDA Designations

No designations recorded

Clinical trial landscape

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus · 1 trial · 4 indications

Phase 3 1
NCT01188343Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese ToddlersJapanese Encephalitis
COMPLETED542 Analytics
PHASE3COMPLETED
Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers
Japanese Encephalitis
NCT01188343542
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Study Endpoints

Primary Endpoints

Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
Day 0 (pre-vaccination) and Day 42 post-vaccination

JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml.

Secondary Endpoints

Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Pre-vaccination and Day 42 post-vaccination
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Pre-vaccination and up to Month 12 post-vaccination
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Pre-vaccination and Day 42 post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALParticipants will receive the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 and Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 42
Group 2EXPERIMENTALParticipants will receive Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 0, and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 42.
Group 3EXPERIMENTALParticipants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0

Interventions

NameTypeDescription
Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusBIOLOGICAL0.5 mL each; Subcutaneous (SC)
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Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria * Aged 12 to 18 months on the day of inclusion . * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg. * Subject in good health based on medical history and physical examination. * Provision of informed consent form signed by at least one parent or other...

Countries:Taiwan
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