This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against
cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological
abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic
HPV types for an additional two years. All subjects who participated in the primary
vaccination study NCT00316693 and who confirmed their interest in participating in a long
term follow up study will therefore be invited to be followed for up to 48 months after
administration of the first dose of vaccine. In addition, safety and persistence of the
humoral immune response will be evaluated in this study.
This protocol posting deals with objectives & outcome measures of the extension phase at
Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a
separate protocol posting (NCT number = NCT00316693).