NCT00937950

Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

Gynaecological Follow-up of a Subset of 580299/008 Study Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,022 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48). This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit. The objectives \& outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
OTHER	Gynaecological follow-up	Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.

Timeline

• Start date: 2009-08-05
• Primary completion: 2014-01-20
• Completion: 2014-01-20
• First posted: 2009-07-13
• Last updated: 2019-10-29
• Results posted: 2015-01-15

Locations

83 sites across 13 countries: United States, Australia, Belgium, Brazil, Canada, Finland, Germany, Italy, Philippines, Spain, Taiwan, Thailand, United Kingdom