NCT00693966

Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females

A Phase II Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this Phase II study is to provide data regarding the safety and immunogenicity for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will provide long-term immune response data. This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.

Detailed description

This is a Phase II double-blind, randomized, dose-comparison, multicenter study in the United States of three different dose levels of MEDI-517 (HPV-16/18 VLP AS04 vaccine) and one dose of MEDI-517 formulated with aluminum hydroxide, with doses administered at 0, 30 and 180 days. Healthy female volunteers 18 through 30 years of age will be entered into 4 treatment arms. The objectives of study are to evaluate reactogenicity, safety and immunogenicity.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)	IM injection
BIOLOGICAL	MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)	IM injection
BIOLOGICAL	MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)	IM injection
BIOLOGICAL	MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)	IM injection

Timeline

• Start date: 1999-10-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2008-06-09
• Last updated: 2016-09-16