NCT01277042

Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,212 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 26 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).

Detailed description

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to: * The removal of 3 outcome measures * The update of 1 outcome measure

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	GSK580299 (CervarixTM)	3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
BIOLOGICAL	Engerix-BTM	3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

Timeline

• Start date: 2011-02-17
• Primary completion: 2011-09-26
• Completion: 2012-02-28
• First posted: 2011-01-14
• Last updated: 2018-08-17
• Results posted: 2013-12-03

Locations

1 site across 1 country: China