At a glance
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Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
In Brief
A Phase 3 clinical trial evaluating Blood sampling for Infections, Papillomavirus and Papillomavirus Vaccines. Completed, enrolled 632 participants across 26 sites in 5 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 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Study Details
Timeline
Interventions
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120