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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00740155 | Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults | PHASE2 | COMPLETED | 154 | — | — | Aug 1, 2008 | Jan 1, 2010 | Mar 3, 2015 | 2 | Mexico |
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Group 4 | EXPERIMENTAL | - |
| Group 5 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105) |
| Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) (Day 0 and Day 105) |
| Tetravalent CYD-1,2,3,4 Dengue (Vero) | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) (Day 0 and Day 105) |
| JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero) | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105) |
Inclusion Criteria : * Healthy as determined by medical history, clinical examination, and biological safety parameters * Aged 18 to 45 years on the day of inclusion. * Informed consent form signed. * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of child...