Efficacy of GSK Bio HPV Vaccine (580299) vs Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16/18 Cervical Infection & Cervical Neoplasia, Administered Intramuscularly According to 0,1,6 Month Schedule in Healthy Females (15-25 Years)
NOTE: Some 178 centers participate in this study. Given that the recruitment is completed,
the researchers have listed one center per country in this website. If required, further
details of centers available on request.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection
CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
580299/008
NCT00122681
May 2004
November 2009
Name | Location |
---|---|
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Lexington, Kentucky 40536-0098 |
GSK Investigational Site | Duluth, Minnesota 55805 |
GSK Investigational Site | Albuquerque, New Mexico 87109 |
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 | Bettendorf, Iowa 52722 |
GSK Investigational Site | Hooksett, New Hampshire 03106 |
GSK Investigational Site | Oklahoma City, Oklahoma 73112 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Salem, Virginia 24153 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Birmingham, Alabama 35209 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Kansas City, Kansas 66160 |
GSK Investigational Site | Omaha, Nebraska 68131 |
GSK Investigational Site | Edison, New Jersey 08837 |
GSK Investigational Site | Oregon City, Oregon 97045 |
GSK Investigational Site | Salt Lake City, Utah 84107 |
GSK Investigational Site | Seattle, Washington 98133 |
GSK Investigational Site | Honolulu, Hawaii 96826 |