NCT00316706

Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,245 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

Summary

This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Cervical Intraepithelial Neoplasia
• Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)	Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule
BIOLOGICAL	Havrix™	Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-04-21
• Last updated: 2012-09-18
• Results posted: 2010-03-01

Locations

28 sites across 5 countries: Colombia, Germany, Honduras, Panama, Taiwan