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Also known as GSK Biological's HPV vaccine GSK580299 (Cervarix™)
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...
GSK Biological's HPV vaccine GSK580299 is an investigational vaccine developed by GSK plc for infections and papillomavirus. It is also known as Cervarix. The vaccine was studied in a Phase 3 safety trial in female healthy volunteers aged 18 years and older in the United States and Canada.
GSK Biological's HPV vaccine GSK580299 is being developed for infections and papillomavirus. Its clinical program targets the prevention of human papillomavirus infection. The only listed trial enrolled healthy female volunteers aged 18 years and older in the United States and Canada.
GSK Biological's HPV vaccine GSK580299 is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine unit associated with the product name. The candidate is also known as Cervarix.
GSK Biological's HPV vaccine GSK580299 is in Phase 3 development. It is an investigational vaccine and is not described as approved. The Phase 3 trial NCT00799825 has been completed, and no active trials are listed for this candidate.
GSK Biological's HPV vaccine GSK580299 was studied in the Phase 3 trial NCT00799825, titled Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US. The trial was completed, enrolled 346 participants, and was conducted in the United States and Canada.
Yes. GSK Biological's HPV vaccine GSK580299 is also known as Cervarix. Both names refer to the same GSK plc vaccine candidate for infections and papillomavirus, which was evaluated in the completed Phase 3 trial NCT00799825 in female healthy volunteers.