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Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus · 1 trial · 4 indications
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.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 |
| Name | Type | Description |
|---|---|---|
| Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus | BIOLOGICAL | 0.5 mL each; Subcutaneous (SC) |
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...
It is a study combination of a Japanese encephalitis chimeric virus vaccine given together with a live attenuated measles, mumps, and rubella vaccine. The combination was evaluated in healthy toddlers to assess whether the two vaccines could be administered together. It targets prevention of Japanese encephalitis along with measles, mumps, and rubella.
It is used for immunization against Japanese encephalitis, measles, mumps, and rubella. The Phase 3 study enrolled healthy toddlers from 12 months of age in Taiwan to evaluate co-administration of the Japanese encephalitis chimeric virus vaccine with the measles, mumps, and rubella vaccine. The program falls within infectious disease prevention.
Sanofi is the developer of this Japanese encephalitis chimeric virus and measles, mumps, and rubella vaccine combination. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company sponsored the Phase 3 co-administration study conducted in Taiwanese toddlers.
The combination has been studied in Phase 3. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and is not an approved product. The completed study was randomized and controlled, with 542 participants enrolled.
The trial is NCT01188343, titled Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers. It was a completed Phase 3 randomized, controlled study that enrolled 542 healthy toddlers aged 12 months and older in Taiwan. It was not double blind and did not use biomarker selection.