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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01190176
First received: August 26, 2010
Last updated: June 25, 2015
Last verified: June 2015
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ 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 ]

Estimated Enrollment: 111
Study Start Date: September 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   28 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190176

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 25 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01190176     History of Changes
Other Study ID Numbers: 113617
Study First Received: August 26, 2010
Last Updated: June 25, 2015
Health Authority: Peru: Instituto Nacional de Salud
Russian Federation: Ministry of Health and social development of Russian Federation, Federal Service on surveillance in healthcare and social development
Singapore: The Health Sciences Authority, Singapore
United States: Food and Drug Administration
Netherlands: Centrale Commissie Mensgesbonden Onderzoek (Central Committee on Research Involving Human Subjects) Den Haag (The Hague), The Netherlands
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Portugal: Ministério da Saude (Ana Jorge)
Canada: Health Products and Food Branch
Philippines: Food and Drug Administration Philippines

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

ClinicalTrials.gov processed this record on July 05, 2015