This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
346
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
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.
Time frame: Throughout the study (up to Month 12)
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
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.
Time frame: Throughout the study (up to Month 12)
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Time frame: Throughout the study (up to Month 12)
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GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Louisville, Colorado, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Iowa City, Iowa, United States
...and 38 more locations