Infections, Papillomavirus
Conditions
Keywords
HPV, HPV vaccine, Cervical neoplasia, Human papillomavirus, Papillomavirus, Cervical cancer, Human papillomavirus (HPV) type 16/18 infections
Brief summary
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
Cervarix or Control \[Al(OH)3\] has been administered in the primary study NCT00294047.
Interventions
PROCEDUREGynaecological follow-up
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.
BIOLOGICALCervarix
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.
BIOLOGICALPlacebo control
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
28 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12 | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24 | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36 | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48 | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12 | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24 | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36 | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48 | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Referral to Colposcopy at Month 12 | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With Referral to Colposcopy at Month 24 | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With Referral to Colposcopy at Month 36 | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With Referral to Colposcopy at Month 48 | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With Referral to Treatment at Month 12 | At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Referral to Treatment at Month 24 | At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Referral to Treatment at Month 36 | At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
| Number of Subjects With Referral to Treatment at Month 48 | At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)] | 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. |
Countries
Canada, Netherlands, Portugal, Russia, Singapore, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted by multiple investigators at 20 centres in Canada, Netherlands, Portugal, Russian Federation, Singapore, United Kingdom and the United States.
Pre-assignment details
Although 34 subjects were enrolled in the study, 2 were excluded following eligibility criteria, leading to 32 subjects who started the study.
Participants by arm
| Arm | Count |
|---|---|
| HPV-062 Study Subjects Group 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HPV-062 Study Subjects Group |
|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized African Heritage / African American | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 28 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12 | 2 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24 | 3 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36 | 3 Participants |
Primary
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.
Time frame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48 | 1 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12 | Normal | 11 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12 | ASC-US | 2 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12 | LSIL | 2 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24 | Normal | 11 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24 | ASC-US | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24 | LSIL | 0 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36 | Normal | 8 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36 | ASC-US | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36 | LSIL | 0 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48 | Normal | 6 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48 | ASC-US | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48 | LSIL | 0 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Colposcopy referral | Yes | 4 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Colposcopy referral | No | 11 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Colposcopy performed | Yes | 4 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Colposcopy performed | No | 11 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Algorithm respected | Yes | 4 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Algorithm respected | No | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Lesion | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 12 | Lesion | No | 3 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Colposcopy referral | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Colposcopy referral | No | 11 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Colposcopy performed | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Colposcopy performed | No | 11 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Algorithm respected | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Algorithm respected | No | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Lesion | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 24 | Lesion | No | 1 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Algorithm respected | Yes | 3 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Algorithm respected | No | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Lesion | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Lesion | No | 3 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Colposcopy referral | Yes | 3 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Colposcopy referral | No | 6 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Colposcopy performed | Yes | 3 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 36 | Colposcopy performed | No | 6 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Colposcopy referral | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Colposcopy referral | No | 5 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Colposcopy performed | Yes | 2 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Colposcopy performed | No | 4 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Algorithm respected | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Algorithm respected | No | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Lesion | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Colposcopy at Month 48 | Lesion | No | 2 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 12 | Treatment referral | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 12 | Treatment referral | No | 4 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 12 | Treatment done | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 12 | Treatment done | No | 4 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 24 | Treatment referral | No | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 24 | Treatment done | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 24 | Treatment done | No | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 24 | Treatment referral | Yes | 0 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Treatment referral | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Loop excision of cervix | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Loop excision of cervix | No | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Loop cone of cervix | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Treatment referral | No | 2 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Treatment done | Yes | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Treatment done | No | 2 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Loop cone of cervix | No | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Cold knife cone of cervix | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Cold knife cone of cervix | No | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Laser excision cone of cervix | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Laser excision cone of cervix | No | 1 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Other | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 36 | Other | No | 1 Participants |
Primary
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)]
Population: The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 48 | Treatment done | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 48 | Treatment referral | Yes | 0 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 48 | Treatment referral | No | 2 Participants |
| HPV-062 Study Subjects Group | Number of Subjects With Referral to Treatment at Month 48 | Treatment done | No | 2 Participants |