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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Solicited adverse event rates (including injection site and systemic reactions)
For 7 days after each injection
Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
580299/005
NCT00693966
October 1999
September 2004
Name | Location |
---|---|
GSK Clinical Trials Call Center | Hoover, Alabama 35216 |
GSK Clinical Trials Call Center | New Orleans, Louisiana 70112 |
GSK Clinical Trials Call Center | Albany, New York 12208 |
GSK Clinical Trials Call Center | Cleveland, Ohio 44106-5065 |
GSK Clinical Trials Call Center | Fort Worth, Texas 76104 |
GSK Clinical Trials Call Center | Salt Lake City, Utah 84109 |