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GSK Biological's HPV vaccine GSK580299 · 1 trial · 1 indication
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...
GSK580299 is an investigational human papillomavirus (HPV) vaccine being developed by GSK plc for the prevention of papillomavirus infections. It is currently in Phase 3 clinical development, meaning it is still being studied and has not yet been approved for use.
GSK580299 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in Phase 3 clinical trials.
GSK580299 is in Phase 3 clinical development. It is an investigational HPV vaccine, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed, but the vaccine remains under study.
GSK580299 has one completed Phase 3 clinical trial, identified as NCT00799825. This study, titled 'Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US,' enrolled 346 female participants aged 18 years and older in the United States and Canada.
Yes, GSK580299 is the same vaccine as GSK Biologicals' human papillomavirus vaccine. The name GSK580299 is the investigational identifier used in clinical trials, and the vaccine is developed by GSK Biologicals, a subsidiary of GSK plc.