This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
199
3-dose schedule intramuscularly vaccination
GSK Investigational Site
Parkville, Victoria, Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Almada, Portugal
Number of Subjects Reporting Serious Adverse Events
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Time frame: Throughout the study (from Month 0 to Month 12)
Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Medically significant conditions (MSCs) are defined as: AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were 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. Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination.
Time frame: Throughout the study (from Month 0 to Month 12)
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Coimbra, Portugal
GSK Investigational Site
Lisbon, Portugal
GSK Investigational Site
Porto, Portugal
GSK Investigational Site
Setúbal, Portugal
GSK Investigational Site
Moscow, Russia
GSK Investigational Site
Moscow, Russia
GSK Investigational Site
Moscow, Russia
...and 5 more locations
Time frame: Throughout the study (from Month 0 to Month 12)