NCT00345878

Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years

Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the HPV-16/18 L1 VLP AS04 vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

The protocol was primarily amended for the following reasons: * Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study. * It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control group at the end of the study. The HPV vaccine will be offered to these subjects based on its local indication once the vaccine is marketed in Malaysia.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
BIOLOGICAL	HPV-16/18 L1 VLP AS04 (Cervarix TM)	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2006-09-25
• Primary completion: 2007-12-21
• Completion: 2007-12-21
• First posted: 2006-06-29
• Last updated: 2018-07-20
• Results posted: 2009-12-15

Locations

2 sites across 1 country: Malaysia