Spots Global Cancer Trial Database for Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
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Trial Identification
Brief Title: Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
Official Title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study
Study ID: NCT01190189
Conditions
Interventions
Study Description
Brief Summary: This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.
Detailed Description: This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.
Eligibility
Minimum Age: 26 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
GSK Investigational Site, Aurora, Colorado, United States
GSK Investigational Site, Golden, Colorado, United States
GSK Investigational Site, Coral Gables, Florida, United States
GSK Investigational Site, Miami, Florida, United States
GSK Investigational Site, Augusta, Georgia, United States
GSK Investigational Site, Iowa City, Iowa, United States
GSK Investigational Site, Wichita, Kansas, United States
GSK Investigational Site, Bardstown, Kentucky, United States
GSK Investigational Site, Louisville, Kentucky, United States
GSK Investigational Site, Omaha, Nebraska, United States
GSK Investigational Site, Lebanon, New Hampshire, United States
GSK Investigational Site, New Bern, North Carolina, United States
GSK Investigational Site, Cleveland, Ohio, United States
GSK Investigational Site, Carnegie, Pennsylvania, United States
GSK Investigational Site, Erie, Pennsylvania, United States
GSK Investigational Site, Erie, Pennsylvania, United States
GSK Investigational Site, Pittsburgh, Pennsylvania, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Salt Lake City, Utah, United States
GSK Investigational Site, Salt Lake City, Utah, United States
GSK Investigational Site, Wenatchee, Washington, United States
GSK Investigational Site, Edmonton, Alberta, Canada
GSK Investigational Site, Vancouver, British Columbia, Canada
GSK Investigational Site, Halifax, Nova Scotia, Canada
GSK Investigational Site, Truro, Nova Scotia, Canada
GSK Investigational Site, Waterloo, Ontario, Canada
GSK Investigational Site, Sherbrooke, Quebec, Canada
GSK Investigational Site, Quebec, , Canada
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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