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Trial record 77 of 91 for:    cervarix

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

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ClinicalTrials.gov Identifier: NCT01190176
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infections, Papillomavirus Procedure: Gynaecological follow-up Biological: Cervarix Biological: Placebo control Phase 3

Detailed Description:
Cervarix or Control [Al(OH)3] has been administered in the primary study NCT00294047.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
Actual Study Start Date : September 12, 2011
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Arm Intervention/treatment
Experimental: HPV-062 study subjects Group
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.
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.




Primary Outcome Measures :
  1. Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12 [ Time Frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.

  2. Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24 [ Time Frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.

  3. Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36 [ Time Frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.

  4. Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48 [ Time Frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.

  5. Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12 [ Time Frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]

    Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).

    Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.


  6. Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24 [ Time Frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]

    Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).

    Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.


  7. Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36 [ Time Frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]

    Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).

    Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.


  8. Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48 [ Time Frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]

    Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).

    Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.


  9. Number of Subjects With Referral to Colposcopy at Month 12 [ Time Frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Detection was done on all subjects irrespective of their baseline HPV DNA status.

  10. Number of Subjects With Referral to Colposcopy at Month 24 [ Time Frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Detection was done on all subjects irrespective of their baseline HPV DNA status.

  11. Number of Subjects With Referral to Colposcopy at Month 36 [ Time Frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Detection was done on all subjects irrespective of their baseline HPV DNA status.

  12. Number of Subjects With Referral to Colposcopy at Month 48 [ Time Frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    Detection was done on all subjects irrespective of their baseline HPV DNA status.

  13. Number of Subjects With Referral to Treatment at Month 12 [ Time Frame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.

  14. Number of Subjects With Referral to Treatment at Month 24 [ Time Frame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.

  15. Number of Subjects With Referral to Treatment at Month 36 [ Time Frame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.

  16. Number of Subjects With Referral to Treatment at Month 48 [ Time Frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] ]
    If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190176


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] August 18, 2010
Statistical Analysis Plan  [PDF] October 22, 2014


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01190176     History of Changes
Other Study ID Numbers: 113617
First Posted: August 27, 2010    Key Record Dates
Results First Posted: October 17, 2018
Last Update Posted: October 17, 2018
Last Verified: September 2018

Keywords provided by GlaxoSmithKline:
HPV
HPV vaccine
Cervical neoplasia
Human papillomavirus
Papillomavirus
Cervical cancer
Human papillomavirus (HPV) type 16/18 infections