A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects - HPV-062 EXT:015
- Conditions
- GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of pre-malignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18.
- Registration Number
- EUCTR2009-017282-35-GB
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 34
•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 HPV-015 and who fulfils either of the following criteria:
-displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding HPV-015 study visit
-was pregnant so that no cervical sample could be collected at her concluding HPV-015 study visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•A subject who at the HPV-015 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
•A subject who at the HPV-015 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her HPV-015 exit colposcopy.
•A subject for whom the cervical cytology results from the concluding HPV-015 study visit were unavailable for reasons other than pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected.;Secondary Objective: -;Primary end point(s): •Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing (Hybrid Capture ® 2 test [HC2]).<br>•Occurrence of cervical cytological abnormalities in cervical samples by ThinPrep® PapTest.<br>•Occurrence of referral to colposcopy.<br>•Occurrence of referral to treatment.<br>
- Secondary Outcome Measures
Name Time Method