Infections, Papillomavirus Clinical Trial
Official title:
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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