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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00157950 | Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED) | PHASE3 | COMPLETED | 176 | — | — | Oct 1, 2005 | Jun 1, 2006 | Feb 4, 2016 | - | — |
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
| Arm | Type | Description |
|---|---|---|
| Gardasil™ | EXPERIMENTAL | Gardasil™ 3 dose regimen |
| Placebo | PLACEBO_COMPARATOR | Gardasil™ matching placebo 3 dose regimen |
| Name | Type | Description |
|---|---|---|
| Gardasil™ | BIOLOGICAL | Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) |
| Placebo | BIOLOGICAL | Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) |
Inclusion Criteria: * Girls ages 9 to 15 years (must not yet have had coitarche) * Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners) Exclusion Criteria: All Subjects: * History of known prior vaccination with an HPV vaccine. Women...