NCT01190176

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 28 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
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.
BIOLOGICAL	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.

Timeline

• Start date: 2011-09-12
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2010-08-27
• Last updated: 2019-10-30
• Results posted: 2018-10-17

Locations

20 sites across 7 countries: United States, Canada, Netherlands, Portugal, Russia, Singapore, United Kingdom