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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01190176
First received: August 26, 2010
Last updated: September 11, 2014
Last verified: August 2014

August 26, 2010
September 11, 2014
September 2011
November 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01190176 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Gynaecological Follow-up of a Subset of HPV-015 Study Subjects

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Infections, Papillomavirus
  • 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.
Experimental: Single Group
NCT00294047 study subjects who had normal cervical cytology but tested positive for oncogenic HPV at their concluding NCT00294047 study visit or were pregnant at their concluding NCT00294047 study visit
Interventions:
  • Procedure: Gynaecological follow-up
  • Biological: Cervarix™
  • Biological: Placebo control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
November 2017
November 2017   (final data collection date for primary outcome measure)

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.
Female
28 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States,   Canada,   Netherlands,   Portugal,   United Kingdom
 
NCT01190176
113617
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP