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

• Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ] [ Designated as safety issue: No ]
• Occurrence of cervical cytological abnormalities in cervical samples [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ] [ Designated as safety issue: No ]
• Occurrence of referral to colposcopy [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ] [ Designated as safety issue: No ]
• Occurrence of referral to treatment [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ] [ Designated as safety issue: No ]

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.

Cervarix™ or control [Al(OH)3] has been administered in the primary study NCT00294047.

• Human Papillomavirus Infection
• Cervical Neoplasia

• Procedure: Gynaecological follow-up
  Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.
• Biological: Cervarix™
  Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
• Biological: Placebo control
  Subjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Inclusion Criteria:

• Written informed consent obtained from the subject prior to enrolment.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:

  • displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding NCT00294047 study visit
  • was pregnant so that no cervical sample could be collected at her concluding NCT00294047 study visit

Exclusion Criteria:

• A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
• A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
• A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.