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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00316706 | Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine | PHASE3 | COMPLETED | 1,245 | — | — | Oct 1, 2005 | Jan 1, 2009 | Sep 18, 2012 | 28 | Colombia, Germany +3 |
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. |
| Havrix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) | BIOLOGICAL | Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule |
| Havrix™ | BIOLOGICAL | Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule. |
Inclusion Criteria: * A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study. * Written informed assent obtained from the subject and written informed consent obt...