Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00937950
First received: July 2, 2009
Last updated: June 17, 2015
Last verified: April 2015
  Purpose

This study is designed provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT 00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT 00122681 study visit (Visit 10, Month 48).

This follow-up study will also be offered to subjects who were pregnant at their last NCT 00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

The objectives & outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).


Condition Intervention Phase
Infections, Papillomavirus
Procedure: Gynaecological follow-up
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 580299/008 Study Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With HPV DNA in Cervical Samples by HCII [ Time Frame: At Months 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Subjects that presented oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture® 2 test [HCII]).

  • Number of Subjects With Colposcopy Referral and Colposcopy Adequacy [ Time Frame: At Months 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Subjects with colposcopy referral and colposcopy adequacy.

  • Number of Subjects With Cervical Cytology [ Time Frame: At Months 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.

  • Number of Subjects With Cervical Biopsy Results [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.

  • Number of Subjects With Cervical Biopsy Results [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.

  • Number of Subjects With Cervical Biopsy Results [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.

  • Number of Subjects With Cervical Biopsy Results [ Time Frame: At Month 48 ] [ Designated as safety issue: No ]
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.

  • Number of Subjects With Treatment Referrals by Treatment Type [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.

  • Number of Subjects With Treatment Referrals by Treatment Type [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.

  • Number of Subjects With Treatment Referrals by Treatment Type [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.

  • Number of Subjects With Treatment Referrals by Treatment Type [ Time Frame: At Month 48 ] [ Designated as safety issue: No ]
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.

  • Number of Subjects With AEs or SAEs Leading to Withdrawal [ Time Frame: Up to Month 48 ] [ Designated as safety issue: No ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication. [ Time Frame: Up to Month 48 ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 2022
Study Start Date: August 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group
Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last 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 four years.

  Eligibility

Ages Eligible for Study:   18 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 should be enrolled in the study.
  • A subject previously enrolled in the study NCT 00122681 and who fulfils either of the following criteria:
  • displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).

or

• was pregnant at her last visit of the NCT 00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.

Exclusion Criteria:

  • A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).
  • A subject who had a cervical lesion at her last NCT 00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT 00122681 exit colposcopy.
  • A subject for whom the cervical cytology results from the last NCT 00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.

If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment.

  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: NCT00937950

  Show 87 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00937950     History of Changes
Other Study ID Numbers: 112024
Study First Received: July 2, 2009
Results First Received: January 8, 2015
Last Updated: June 17, 2015
Health Authority: Finland: Finnish Medicines Agency
Spain: Agencia Española del Medicamento y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: FAGG
Mexico: Ministry of Health - Secretaria de Salud - Comisión de Autorización Sanitaria - Comisión Federal para la Protección cotnra riesgos de salud
Canada: Biologics and Genetic Therapies Directorate (BGTD)
Taiwan: Department of Health
Thailand: The Ethical Review Committee for Research in Human Subjects, Ministry of Public health
Brazil: ANVISA
Philippines: Bureau of Food and Drugs
Italy: Comitato Etico Provinciale di Modena, Policlinico di Modena Azienda Ospedaliera
Germany: Paul-Ehrlich-Institut
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Human papillomavirus
HPV
Papillomavirus
HPV vaccine
Cervical cancer

ClinicalTrials.gov processed this record on September 01, 2015