Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

Gynaecological Follow-up of a Subset of 580299/008 Study Subjects

This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48).

This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 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).

Study Overview

• Status: Completed
• Conditions: Infections, Papillomavirus
• Intervention / Treatment: Other: Gynaecological follow-up

• Study Type: Interventional
• Enrollment (Actual): 2022
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
  • Tasmania
    • Hobart, Tasmania, Australia
      • GSK Investigational Site
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • GSK Investigational Site
    • Parkville, Victoria, Australia, 3052
      • GSK Investigational Site
  • Western Australia
    • Perth, Western Australia, Australia
      • GSK Investigational Site
• Belgium
  • Brussels, Belgium, 1090
    • GSK Investigational Site
  • Edegem, Belgium, 2650
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
• Brazil
  • Campinas, Brazil, 13083-970
    • GSK Investigational Site
  • Curitiba, Brazil, 80060-150
    • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • GSK Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • GSK Investigational Site
  • British Columbia
    • Langley, British Columbia, Canada, V3A 4H9
      • GSK Investigational Site
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Quebec
    • Beauport, Quebec, Canada, G1E 7G9
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2K 4L5
      • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00610
    • GSK Investigational Site
  • Jyvaskyla, Finland, 40100
    • GSK Investigational Site
  • Kotka, Finland, 48100
    • GSK Investigational Site
  • Kouvola, Finland, 45100
    • GSK Investigational Site
  • Kuopio, Finland, 70100
    • GSK Investigational Site
  • Lahti, Finland, 15110
    • GSK Investigational Site
  • Lappeenranta, Finland, 53100
    • GSK Investigational Site
  • Mikkeli, Finland, 50100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Rauma, Finland, 26100
    • GSK Investigational Site
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20100
    • GSK Investigational Site
  • Vaasa, Finland, 65100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13086
    • GSK Investigational Site
  • Berlin, Germany, 13125
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 22159
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Karlsruhe, Baden-Wuerttemberg, Germany, 76199
      • GSK Investigational Site
    • Ravensburg, Baden-Wuerttemberg, Germany, 88212
      • GSK Investigational Site
    • Rheinstetten, Baden-Wuerttemberg, Germany, 76287
      • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 80637
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60439
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30657
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04279
      • GSK Investigational Site
  • Thueringen
    • Nordhausen, Thueringen, Germany, 99734
      • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41100
      • GSK Investigational Site
• Philippines
  • Cavite, Philippines
    • GSK Investigational Site
  • Laguna, Philippines
    • GSK Investigational Site
  • Las Pinas City, Philippines
    • GSK Investigational Site
  • Los Banos, Laguna, Philippines, 4027
    • GSK Investigational Site
  • Makati City, Philippines, 1231
    • GSK Investigational Site
  • Manila, Philippines, 1004
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • L'Hospitalet de Llobregat, Spain, 08907
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Móstoles/Madrid, Spain, 28935
    • GSK Investigational Site
• Taiwan
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Taipei, Taiwan, 114
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10400
    • GSK Investigational Site
  • Bangkok, Thailand, 10330
    • GSK Investigational Site
  • Bangkok, Thailand, 10700
    • GSK Investigational Site
• United Kingdom
  • Aberdeen, United Kingdom, AB25 7ZD
    • GSK Investigational Site
  • London, United Kingdom, EC1M 6BQ
    • GSK Investigational Site
  • Manchester, United Kingdom, M13 0JH
    • GSK Investigational Site
• United States
  • Florida
    • Clearwater, Florida, United States, 33759
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • GSK Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10029
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • GSK Investigational Site
    • New Bern, North Carolina, United States, 28562
      • GSK Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74105
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • GSK Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • GSK Investigational Site
    • Erie, Pennsylvania, United States, 16507
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Pleasant Hills, Pennsylvania, United States, 15236
      • GSK Investigational Site
  • Washington
    • Wenatchee, Washington, United States, 98801
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 NCT00122681 and who fulfils either of the following criteria:

  • displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).

or

- was pregnant at her last visit of the NCT00122681 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 NCT00122681 study visit (Visit 10, Month 48).
• A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.
• A subject for whom the cervical cytology results from the last NCT00122681 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: HPV-052 study subjects Group; The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.

Other: Gynaecological follow-up; Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)	Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).	At Months 12, 24, 36, 48
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy	Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.	At Months 12, 24, 36, 48
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest	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. Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.	At Months 12, 24, 36, 48
Number of Subjects With Cervical Biopsy Results at Month 12	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. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 12
Number of Subjects With Cervical Biopsy Results at Month 24	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. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 24
Number of Subjects With Cervical Biopsy Results at Month 36	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. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 36
Number of Subjects With Cervical Biopsy Results at Month 48	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. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.	At Month 48
Number of Subjects With Treatment Referrals by Treatment Type at Month 12	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 12
Number of Subjects With Treatment Referrals by Treatment Type at Month 24	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 24
Number of Subjects With Treatment Referrals by Treatment Type at Month 36	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 36
Number of Subjects With Treatment Referrals by Treatment Type at Month 48	If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.	At Month 48
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal	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.	From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.	SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.	From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• IPD for this study will be made available via the Clinical Study Data Request site.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2009
• Primary Completion (Actual): January 20, 2014
• Study Completion (Actual): January 20, 2014

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Human papillomavirus; HPV; Cervical cancer; Papillomavirus; HPV vaccine
• Other Study ID Numbers: 112024; 2008-008124-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study is available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR