At a glance
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Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
In Brief
A Phase 3 clinical trial evaluating Blood sampling and Cervico-vaginal secretion (CVS) samples for Infections, Papillomavirus. Completed, enrolled 525 participants across 6 sites in 2 countries.
Detailed Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives \& outcome measures of the extension phase from Year 5 to Year 10. The objectives \& outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).
Study Details
Timeline
Interventions
Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.
CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.