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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00423046 | Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age | PHASE3 | COMPLETED | 1,106 | — | — | Jan 24, 2007 | May 14, 2012 | Jan 2, 2020 | 40 | United States |
Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects received 3 doses of GSK Biologicals human papillomavirus \[HPV\]16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. |
| Gardasil Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Gardasil® (Merck's human papillomavirus \[HPV\] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) | BIOLOGICAL | Three doses administered intramuscularly at months 0, 1 and 6 |
| Gardasil ® (Merck & Co. Inc) | BIOLOGICAL | Three doses administered intramuscularly at months 0, 2 and 6 |
| Placebo | BIOLOGICAL | One dose administered intramuscularly at month 1 to maintain blinding |
Inclusion Criteria: * A woman whom the investigator believes that she or her legally acceptable representative (in the event that the subject is illiterate) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * A woman betwee...