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

NCT00937950 | Completed Phase 3 Results

• 2 other identifiers: 1120242008-008124-33
• Study Type: interventional
• Target: 2,022
• Locations: 13 countries
• Sites: 83

Brief Summary

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).

Conditions

Infections, Papillomavirus

Keywords

HPV; Papillomavirus; Human papillomavirus; Cervical cancer; HPV vaccine

Outcome Measures

Primary Outcomes (13)

• 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]

Study Arms (1)

HPV-052 study subjects Group

OTHER

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

Interventions

Gynaecological follow-up OTHER

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.

HPV-052 study subjects Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (83)

GSK Investigational Site

Clearwater, Florida, 33759, United States

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Miami, Florida, 33136, United States

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Honolulu, Hawaii, 96826, United States

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Iowa City, Iowa, 52242, United States

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Wichita, Kansas, 67207, United States

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Bardstown, Kentucky, 40004, United States

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Omaha, Nebraska, 68131, United States

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Albuquerque, New Mexico, 87131, United States

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New York, New York, 10029, United States

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Chapel Hill, North Carolina, 27514, United States

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New Bern, North Carolina, 28562, United States

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Tulsa, Oklahoma, 74105, United States

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Portland, Oregon, 97210, United States

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Erie, Pennsylvania, 16507, United States

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Erie, Pennsylvania, 16508, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pleasant Hills, Pennsylvania, 15236, United States

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Wenatchee, Washington, 98801, United States

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Westmead, New South Wales, 2145, Australia

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Hobart, Tasmania, Australia

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Carlton, Victoria, 3053, Australia

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Parkville, Victoria, 3052, Australia

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Perth, Western Australia, Australia

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Campinas, 13083-970, Brazil

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Curitiba, 80060-150, Brazil

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Edmonton, Alberta, T6G 2C8, Canada

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Langley, British Columbia, V3A 4H9, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Beauport, Quebec, G1E 7G9, Canada

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Montreal, Quebec, H2K 4L5, Canada

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Helsinki, 00610, Finland

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Jyväskylä, 40100, Finland

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Kotka, 48100, Finland

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Kouvola, 45100, Finland

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Kuopio, 70100, Finland

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Lahti, 15110, Finland

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Lappeenranta, 53100, Finland

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Mikkeli, 50100, Finland

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Oulu, 90220, Finland

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Pori, 28100, Finland

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Rauma, 26100, Finland

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Seinäjoki, 60100, Finland

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Tampere, 33100, Finland

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Turku, 20100, Finland

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Vaasa, 65100, Finland

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Karlsruhe, Baden-Wurttemberg, 76199, Germany

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Ravensburg, Baden-Wurttemberg, 88212, Germany

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Rheinstetten, Baden-Wurttemberg, 76287, Germany

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Munich, Bavaria, 80637, Germany

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Würzburg, Bavaria, 97070, Germany

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Frankfurt am Main, Hesse, 60439, Germany

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Hanover, Lower Saxony, 30657, Germany

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Mainz, Rhineland-Palatinate, 55116, Germany

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Leipzig, Saxony, 04279, Germany

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Nordhausen, Thuringia, 99734, Germany

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Berlin, 13086, Germany

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Berlin, 13125, Germany

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Hamburg, 20246, Germany

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Hamburg, 22159, Germany

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Modena, Emilia-Romagna, 41100, Italy

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Cavite, Philippines

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Laguna, Philippines

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Las Piñas, Philippines

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Los Banos, Laguna, 4027, Philippines

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Makati City, 1231, Philippines

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Manila, 1004, Philippines

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Barcelona, 08035, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28040, Spain

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Móstoles/Madrid, 28935, Spain

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GSK Investigational Site

Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taipei, 114, Taiwan

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GSK Investigational Site

Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Aberdeen, AB25 7ZD, United Kingdom

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London, EC1M 6BQ, United Kingdom

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GSK Investigational Site

Manchester, M13 0JH, United Kingdom

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Related Links

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

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 13, 2009
• Study Start: August 5, 2009
• Primary Completion: January 20, 2014
• Study Completion: January 20, 2014
• Last Updated: October 29, 2019
• Results First Posted: January 15, 2015

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.

Locations

CA (5); US (18); AU (5); FI (15); DE (14); IT (1); ES (4); TW (3); GB (3); BR (3); BE (3); TH (3); PH (6)