Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Women's Studies, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 28 - Any |
| Updated: | 10/19/2018 |
| Start Date: | September 12, 2011 |
| End Date: | September 20, 2017 |
Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
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.
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.
Cervarix or Control [Al(OH)3] has been administered in the primary study NCT00294047.
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.
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials