Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects
Condition: Infections, Papillomavirus
Intervention: Gynaecological follow-up
Intervention description: Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2022.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HPV; Papillomavirus; Human papillomavirus; Cervical cancer; HPV vaccine

Summary:

      This study is designed to provide up to four years of annual oncogenic HPV DNA testing and
      cervical cytology examination for NCT00122681 study subjects who displayed normal cervical
      cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study
      visit (Visit 10, Month 48).

      This follow-up study will also be offered to subjects who were pregnant at their last
      NCT00122681 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).
    

Eligibility criteria:

        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 NCT00122681 and who fulfils either of the
             following criteria:

               -  displayed normal cervical cytology but tested positive for oncogenic HPV
                  infection at her last NCT00122681 study visit (Visit 10, Month 48).

        or

        - was pregnant at her last visit of the NCT00122681 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 NCT00122681 study visit (Visit 10, Month 48).

          -  A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10,
             Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit
             colposcopy.

          -  A subject for whom the cervical cytology results from the last NCT00122681 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.