Gynaecological Follow-up of a Subset of HPV-015 Study Subjects

This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit. Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit. The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

本研究旨在为在NCT00294047研究末次访视中宫颈细胞学结果正常但致癌性人乳头瘤病毒（HPV）检测呈阳性的受试者，提供最长四年的年度致癌性HPV DNA检测与宫颈细胞学检查服务。对于在NCT00294047研究末次访视时已妊娠、彼时无法采集宫颈样本的女性，亦可纳入本研究。NCT00294047主要试验阶段的研究目标与结局指标，将在单独的试验方案公示文件中予以说明。