This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
164
Three intramuscular injections
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Campinas, Brazil
GSK Investigational Site
Curitiba, Brazil
GSK Investigational Site
Fortaleza, Brazil
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the study period (from Month 0 up to Month 12)
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Time frame: Throughout the study period (from Month 0 up to Month 12)
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs include AEs 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: Throughout the study period (from Month 0 up to Month 12)
Number of Pregnant Subjects Reporting Pregnancy Outcomes
The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Time frame: Throughout the study period (from Month 0 up to Month 12)
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GSK Investigational Site
São Paulo, Brazil