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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00799825 | Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US | PHASE3 | COMPLETED | 346 | — | — | Jan 1, 2009 | Aug 2, 2012 | Jul 12, 2018 | 48 | United States, Canada |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.
MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.
| Arm | Type | Description |
|---|---|---|
| Cervarix group | EXPERIMENTAL | Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule. |
| Name | Type | Description |
|---|---|---|
| GSK Biological's HPV vaccine GSK580299 (Cervarix™) | BIOLOGICAL | All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule. |
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 subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot re...