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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00426361 | Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects | PHASE3 | COMPLETED | 751 | — | — | Feb 13, 2007 | Jul 25, 2008 | Jul 20, 2018 | 38 | France, Germany +1 |
Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6. |
| Boostrix Polio → Cervarix Group | EXPERIMENTAL | Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 1, 2 and 7. |
| Cervarix + Boostrix Polio Group | EXPERIMENTAL | Subjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. |
| Name | Type | Description |
|---|---|---|
| Boostrix ® Polio | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively |
Inclusion Criteria: * Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 10 and 18 years of age at the time of the first...