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 008/580299 and received the control vaccine (Hepatitis A vaccine).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,239
All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Campinas, Brazil
GSK Investigational Site
Curitiba, Brazil
GSK Investigational Site
Taipei, Taiwan
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. Note: Results from one center where compliance issues were discovered are presented also separately.
Time frame: During the entire study period (up to Month 12)
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: During the entire study period (up to Month 12)
Number of Subjects With Pregnancies and Pregnancy Outcomes
The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.
Time frame: During the entire study period (up to Month 12)
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GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Bangkok, Thailand