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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00369824 | Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects | PHASE3 | COMPLETED | 1,330 | — | — | Sep 26, 2006 | Feb 13, 2008 | Jul 20, 2018 | 50 | United States |
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Concentrations given as Geometric Means Concentrations (GMCs)
Titers given as Geometric Mean Titers (GMTs)
| Arm | Type | Description |
|---|---|---|
| Cervarix + Boostrix/Menactra Group | EXPERIMENTAL | Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6. |
| Cervarix + Menactra/Boostrix Group | EXPERIMENTAL | Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6. |
| Cervarix + Boostrix + Menactra Group | EXPERIMENTAL | Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6. |
| Boostrix/Cervarix Group | EXPERIMENTAL | Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7. |
| Menactra/Cervarix Group | EXPERIMENTAL | Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7. |
| Cervarix Group | EXPERIMENTAL | Subjects received Cervarix at Months 0, 1 and 6. |
| Name | Type | Description |
|---|---|---|
| Different formulations of GSK Biologicals' HPV vaccine (580299) | BIOLOGICAL | Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively |
| Menactra TM | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| Boostrix TM | BIOLOGICAL | One dose of vaccine administered intramuscularly |
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, 11 and 18 years of age at the time of the first vaccination. * Written informed consent obtained fro...