Status:
COMPLETED
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
28+ years
Phase:
PHASE3
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 displaye...
Detailed Description
Cervarix or Control \[Al(OH)3\] has been administered in the primary study NCT00294047.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01190176
Start Date
September 12 2011
End Date
September 20 2017
Last Update
October 30 2019
Active Locations (20)
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1
GSK Investigational Site
Iowa City, Iowa, United States, 52242
2
GSK Investigational Site
Wichita, Kansas, United States, 67207
3
GSK Investigational Site
Wenatchee, Washington, United States, 98801
4
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8