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.
Cervarix or Control \[Al(OH)3\] has been administered in the primary study NCT00294047.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
34
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.
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.
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.
GSK Investigational Site
Iowa City, Iowa, United States
GSK Investigational Site
Wichita, Kansas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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GSK Investigational Site
Wenatchee, Washington, United States
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Amsterdam, Netherlands
GSK Investigational Site
Rotterdam, Netherlands
...and 10 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]