NCT00779766

Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,081 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits. Originally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48). The protocol posting has been updated as the study was extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.

Detailed description

This protocol posting has been updated following protocol amendment 6 dated 24 April 2014.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV GSK 580299 vaccine	Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
BIOLOGICAL	Placebo control	Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Timeline

• Start date: 2008-10-22
• Primary completion: 2011-09-06
• Completion: 2016-02-28
• First posted: 2008-10-24
• Last updated: 2019-06-10
• Results posted: 2012-05-10

Locations

4 sites across 1 country: China