Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]
This Protocol Posting has been updated following Protocol Amendment 25, November 2010
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibody Titers in Females 18-26 Years of Age
The data are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
At Month 7
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
108933
NCT00423046
January 2007
May 2012
Name | Location |
---|---|
GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Lexington, Kentucky 40536-0098 |
GSK Investigational Site | Springfield, Massachusetts 01107 |
GSK Investigational Site | Duluth, Minnesota 55805 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Royal Oak, Michigan 48073 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Coeur d'Alene, Idaho 83814 |
GSK Investigational Site | Kansas City, Kansas 66160 |
GSK Investigational Site | Omaha, Nebraska 68131 |
GSK Investigational Site | Cranston, Rhode Island 02920 |
GSK Investigational Site | Salt Lake City, Utah 84107 |
GSK Investigational Site | Seattle, Washington 98133 |