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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00520598 | Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) | PHASE2 | COMPLETED | 511 | — | — | Oct 1, 2007 | May 1, 2011 | Nov 26, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen. |
| 2 | EXPERIMENTAL | Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen. |
| 3 | EXPERIMENTAL | Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen |
| 4 | EXPERIMENTAL | Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection |
| 5 | EXPERIMENTAL | Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection |
| Name | Type | Description |
|---|---|---|
| Comparator: V505 formulation 1 | BIOLOGICAL | 0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6. |
| Comparator: V505 formulation 2 | DRUG | 0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6. |
| Comparator: V505 formulation 3 | BIOLOGICAL | 0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6. |
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant | BIOLOGICAL | 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6. |
| Comparator: Placebo (unspecified) | BIOLOGICAL | 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2. |
Inclusion Criteria: * Female between 16 to 26 years old * Has never had Pap testing or have only had normal Pap test results * Lifetime history of 0 to 4 sexual partners Exclusion Criteria: * History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external ge...