A phase IIIb, open, multi centre gynaecological extension study for follow-up of a subset of 580299/008 study subjects who were either cervical cytology negative and oncogenic HPV positive or pregnant at their final 580299/008 study visit (Visit 10 at Month 48). - HPV-052 EXT 008
- Conditions
- GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.
- Registration Number
- EUCTR2008-008124-33-GB
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 2022
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 should be enrolled in the study.
A subject previously enrolled in the study HPV-008 and who fulfils either of the following criteria:
displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48).
or was pregnant at her last visit of the HPV-008 study (Visit 10, Month 48) so that no cervical sample could be collected at that 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 displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48).
A subject who had a cervical lesion at her last HPV-008 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the HPV-008 exit colposcopy.
A subject for whom the cervical cytology results from the last HPV-008 study visit (Visit 10, Month 48) 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
- Secondary Outcome Measures
Name Time Method