NCT00689741

Efficacy Study of HPV-16/18 Vaccine (GSK 580299) to Prevent HPV-16 and/or -18 Cervical Infection in Young Healthy Women

A Double-blind, Placebo-controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,113 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women. A vaccine that prevents, or even reduces, the incidence of the common types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant reduction in the incidence of cervical cancer and cancer-related mortality, as well as a reduction in the incidence of surgical procedures following abnormal Pap smears.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix	3 doses of IM injection
BIOLOGICAL	placebo	3 doses of IM injection of Al(OH)3 placebo

Timeline

• Start date: 2001-01-01
• Primary completion: 2003-04-01
• Completion: 2003-04-01
• First posted: 2008-06-04
• Last updated: 2016-09-12