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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00652938 | Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects | PHASE3 | COMPLETED | 744 | — | — | Apr 9, 2008 | Jan 8, 2010 | Aug 17, 2018 | 7 | Netherlands, Sweden |
Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.
Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.
Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.
| Arm | Type | Description |
|---|---|---|
| Cervarix & Engerix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) co-administered with Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule. |
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) according to a 0, 1, 6-month schedule. |
| Engerix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule. |
| Name | Type | Description |
|---|---|---|
| HPV Vaccine (GSK580299) Cervarix TM | BIOLOGICAL | IM administration |
| Engerix B | BIOLOGICAL | IM administration |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A fema...