Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

Official Title

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.

Trial Description

Primary Outcome:

  • Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing
  • Occurrence of cervical cytological abnormalities in cervical samples
  • Occurrence of referral to colposcopy
  • Occurrence of referral to treatment
Cervarix™ or control [Al(OH)3] has been administered in the primary study NCT00294047.

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