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Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females

Infections, Papillomavirus Clinical Trial

Official title:
Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, AS04, or Without Adjuvant, in Healthy Adult Female Volunteers

Clinical Trial Summary

The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected.

This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.

Clinical Trial Description

This is a Phase II, double-blind, randomized, comparative trial of three formulations of MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this study will be healthy females 18 through 30 years of age. The study collects safety, reactogenicity and immunogenicity data of MEDI-517 with and without adjuvant. Extended follow-up will provide long-term immune response data. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00693615
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date October 2000
Completion date January 2005
View Details
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