We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190176
First Posted: August 27, 2010
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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 Intervention Phase
Infections, Papillomavirus Procedure: Gynaecological follow-up Biological: Cervarix™ Biological: Placebo control Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ]
  • Occurrence of cervical cytological abnormalities in cervical samples [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ]
  • Occurrence of referral to colposcopy [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ]
  • Occurrence of referral to treatment [ Time Frame: Throughout the study (month 12 to month 48 post last study visit study NCT00294047) ]

Enrollment: 34
Actual Study Start Date: September 12, 2011
Study Completion Date: September 20, 2017
Primary Completion Date: September 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   28 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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


  Hide Study Locations
Locations
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
GSK Investigational Site
Quebec, Canada, G1S 2L6
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1007 MB
GSK Investigational Site
Delft, Netherlands, 2625 AD
GSK Investigational Site
Rotterdam, Netherlands, 3015 CE
Portugal
GSK Investigational Site
Almada, Portugal, 2805-267 Almada
GSK Investigational Site
Coimbra, Portugal, 3000-075 Coimbra
GSK Investigational Site
Lisboa, Portugal, 1200-831 Lisboa
GSK Investigational Site
Porto, Portugal, 4200-023 Porto
GSK Investigational Site
Setúbal, Portugal, 2910-446 Setúbal
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 109263
GSK Investigational Site
Sankt-Petersburg, Russian Federation, 199034
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 229899
United Kingdom
GSK Investigational Site
Aberdeen, United Kingdom, AB25 2ZN
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
London, United Kingdom, W2 1NY
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01190176     History of Changes
Other Study ID Numbers: 113617
First Submitted: August 26, 2010
First Posted: August 27, 2010
Last Update Posted: October 26, 2017
Last Verified: October 2017

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