Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00735644 | Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines | PHASE3 | COMPLETED | 1,200 | — | — | Aug 1, 2008 | Aug 1, 2009 | Apr 21, 2015 | 8 | Philippines, Thailand |
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...