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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00637195 | Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299) | PHASE3 | COMPLETED | 152 | — | — | Mar 11, 2008 | Jun 18, 2009 | Jan 3, 2020 | 2 | Belgium |
A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).
Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| Cervarix™ & Engerix™ Group | EXPERIMENTAL | Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12). |
| Engerix™ Group | ACTIVE_COMPARATOR | Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12). |
| Name | Type | Description |
|---|---|---|
| Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) | BIOLOGICAL | Intramuscular administration, 3 doses. |
| Engerix™ | BIOLOGICAL | Intramuscular administration, 4 doses. |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 20 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from ...