NCT01190189

Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 26 Years
• Healthy volunteers: Accepted

Summary

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Detailed description

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	GSK580299 (Cervarix)	3-dose schedule intramuscularly vaccination

Timeline

• Start date: 2011-04-01
• Primary completion: 2017-11-23
• Completion: 2017-11-23
• First posted: 2010-08-27
• Last updated: 2019-06-19
• Results posted: 2018-12-17

Locations

28 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study