A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above
The Protocol Posting has been updated due to protocol amendment 5 and in order to comply
with the FDA Amendment Act, Sep 2007.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Up to Month 48
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Peru: Instituto Nacional de Salud
104820
NCT00294047
February 2006
March 2014
Name | Location |
---|---|
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 | Green Bay, Wisconsin 54301 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Bettendorf, Iowa 52722 |
GSK Investigational Site | Hooksett, New Hampshire 03106 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Kansas City, Kansas 66160 |
GSK Investigational Site | Omaha, Nebraska 68131 |
GSK Investigational Site | Oregon City, Oregon 97045 |
GSK Investigational Site | Salt Lake City, Utah 84107 |
GSK Investigational Site | Seattle, Washington 98133 |