Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects

• Evaluation of the presence of oncogenic HPV DNA in cervical samples by HPV DNA testing [ Time Frame: Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first ] [ Designated as safety issue: No ]
• Evaluation of cervical cytological abnormalities in cervical samples [ Time Frame: Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first ] [ Designated as safety issue: No ]
• Occurrence of referral to colposcopy. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Evaluation of colposcopy outcomes and biopsy results according to local laboratories. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Occurrence of referrals to treatment. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Evaluation of local cervical therapy performed and treatment biopsy results according to local laboratories. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Occurrence of fatal SAEs. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Occurrence and intensity of SAEs assessed as possibly related to study participation. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Occurrence and intensity of SAEs assessed as possibly related to a concurrent GSK medication. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
• Withdrawals from the study due to AEs and SAEs. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

This study is designed provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT 00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT 00122681 study visit (Visit 10, Month 48).

This follow-up study will also be offered to subjects who were pregnant at their last NCT 00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

The objectives & outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).

• Human Papillomavirus (HPV) Type 16/18 Infections
• Cervical Neoplasia

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 should be enrolled in the study.
• A subject previously enrolled in the study NCT 00122681 and who fulfils either of the following criteria:
• displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).

or

• was pregnant at her last visit of the NCT 00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

Exclusion Criteria:

• A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).
• A subject who had a cervical lesion at her last NCT 00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT 00122681 exit colposcopy.
• A subject for whom the cervical cytology results from the last NCT 00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.

If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment.