NCT00849381

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,239 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 26 Years
• Healthy volunteers: Accepted

Summary

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	GSK580299, GSK Biological's HPV vaccine	All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-02-23
• Last updated: 2014-09-12
• Results posted: 2014-08-25

Locations

9 sites across 3 countries: Brazil, Taiwan, Thailand