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Also known as ChimeriVax™-JE
Japanese Encephalitis Vaccine · 1 trial · 2 indications
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.
| Arm | Type | Description |
|---|---|---|
| JE-CV GPO MBP (Lot 1) | EXPERIMENTAL | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. |
| JE-CV GPO MBP (Lot 2) | EXPERIMENTAL | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2. |
| JE-CV GPO MBP (Lot 3) | EXPERIMENTAL | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3. |
| JE-CV WRAIR (Group 4) | ACTIVE_COMPARATOR | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) |
| Hepatitis A (Group 5) | SHAM_COMPARATOR | Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine |
| Name | Type | Description |
|---|---|---|
| Japanese encephalitis vaccine | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Japanese encephalitis vaccine (Acambis) | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Hepatitis A vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Aged 12 to 18 months on the day of inclusion. * In good general health, without significant medical history. * Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by l...
It is used to prevent Japanese Encephalitis, a viral infection of the brain. The vaccine is developed by Sanofi and is given to protect against the disease. It is also studied in a Phase 3 trial that included hepatitis A as a condition.
Sanofi develops the Japanese Encephalitis Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the clinical program for this vaccine.
The Japanese Encephalitis Vaccine is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The vaccine is not described as approved and remains an investigational product in clinical development.
The Japanese Encephalitis Vaccine has been studied in one completed Phase 3 trial, NCT00735644, titled Study of ChimeriVax-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines. The trial enrolled 1,200 participants, was randomized, and used an active control.
The Phase 3 trial NCT00735644 was a randomized, active-controlled study that enrolled 1,200 healthy volunteers aged 12 months and older. It was conducted in the Philippines and Thailand and included Japanese Encephalitis and hepatitis A as conditions. The trial is completed.