Last updated: 07/17/2024 15:26:55

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

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GSK study ID
113617
See study documents
Clinicaltrials.gov ID
NCT01190176
See results summary
EudraCT ID
2009-017282-35
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 12

Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 24

Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 36

Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 48

Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 12

Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 24

Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 36

Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 48

Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to colposcopy at Month 12

Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to colposcopy at Month 24

Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to colposcopy at Month 36

Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to colposcopy at Month 48

Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to treatment at Month 12

Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to treatment at Month 24

Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to treatment at Month 36

Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Number of subjects with referral to treatment at Month 48

Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]

Secondary outcomes:
Not applicable
Interventions:
  • Procedure/surgery: Gynaecological follow-up
  • Biological/vaccine: Cervarix
  • Biological/vaccine: Placebo control
    • Enrollment:
    34
    Primary completion date:
    2017-20-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to September 2017
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    28+ years
    Accepts healthy volunteers
    Yes
    • 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 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.
    Inclusion and exclusion 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.
      • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Almada, Portugal, 2805-267 Almada
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Amsterdam, Netherlands, 1007 MB
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Coimbra, Portugal, 3000-075 Coimbra
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Edmonton, Alberta, Canada, T6G 2C8
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Halifax, Nova Scotia, Canada, B3K 6R8
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Iowa City, Iowa, United States, 52242
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 20 Results

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2017-20-09
    Actual study completion date
    2017-20-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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