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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00551187 | A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) | PHASE2 | COMPLETED | 620 | — | — | Oct 1, 2007 | May 1, 2009 | Jun 8, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
| 2 | PLACEBO_COMPARATOR | Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
| Name | Type | Description |
|---|---|---|
| V504 | BIOLOGICAL | V504 0.5 ml injection in 3 dose regimen for 6 month treatment period. |
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | BIOLOGICAL | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period. |
| Comparator: Placebo (unspecified) | BIOLOGICAL | V504 Placebo in 3 dose regimen for 6 month treatment period. |
Inclusion Criteria: * Females between 16- to 26-years-old * Has never had Pap testing or has 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...