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

Infections, Papillomavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190176
• Other study ID #: 113617
• Secondary ID: 2009-017282-35
• Status: Completed
• Phase: Phase 3
• Start date: September 12, 2011
• Est. completion date: September 20, 2017

Study information

• Verified date: October 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 28 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Infections, Papillomavirus

Intervention

Procedure:
• Gynaecological 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.

Biological:
• Cervarix
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.
• Placebo 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.

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Rotterdam
Portugal	GSK Investigational Site	Almada
Portugal	GSK Investigational Site	Coimbra
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Setúbal
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Sankt-Petersburg
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Portugal,  Russian Federation,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary	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)]
Primary	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)]
Primary	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)]
Primary	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)]
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.	At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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.	At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]