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

Study Overview
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Brief Summary
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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.

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

Official Title
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Gynaecological Follow-up of a Subset of HPV-015 Study Subjects

Conditions
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Infections, Papillomavirus

Intervention / Treatment
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* Procedure: Gynaecological follow-up
* Biological: Cervarix
* Biological: Placebo control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV-062 study subjects Group<br>HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit. | Procedure: Gynaecological follow-up<br>* 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.<br>Biological: Cervarix<br>* 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.<br>Biological: Placebo control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12 | Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm. | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24 | Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm. | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36 | Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm. | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48 | Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm. | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium. | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium. | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium. | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium. | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Colposcopy at Month 12 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Colposcopy at Month 24 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Colposcopy at Month 36 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Colposcopy at Month 48 | Detection was done on all subjects irrespective of their baseline HPV DNA status. | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Treatment at Month 12 | If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended. | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Treatment at Month 24 | If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended. | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Treatment at Month 36 | If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended. | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 
| Number of Subjects With Referral to Treatment at Month 48 | If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended. | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, HPV vaccine, Cervical neoplasia, Human papillomavirus, Papillomavirus, Cervical cancer, Human papillomavirus (HPV) type 16/18 infections