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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02114385 | A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020) | PHASE3 | COMPLETED | 500 | — | — | Mar 24, 2014 | Apr 22, 2015 | Nov 1, 2018 | 7 | Belgium, Germany +1 |
Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.
| Arm | Type | Description |
|---|---|---|
| V503 | EXPERIMENTAL | 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
| GARDASIL | ACTIVE_COMPARATOR | Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
| Name | Type | Description |
|---|---|---|
| V503 | BIOLOGICAL | 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection |
| GARDASIL | BIOLOGICAL | Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection |
Inclusion Criteria: * Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment. * Subject is a man who has had no more than 5 lifetime female sexual partners. * Subject is judged to be in good physical health on the basis of medical history, physic...