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Brief Title: Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
Official Title: Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing
Study ID: NCT00541970
Brief Summary: Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.
Detailed Description:
Minimum Age: 9 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
GSK Investigational Site, Edmonton, Alberta, Canada
GSK Investigational Site, Langley, British Columbia, Canada
GSK Investigational Site, St. John's, Newfoundland and Labrador, Canada
GSK Investigational Site, Truro, Nova Scotia, Canada
GSK Investigational Site, Quebec City, Quebec, Canada
GSK Investigational Site, Karlsruhe, Baden-Wuerttemberg, Germany
GSK Investigational Site, Kehl, Baden-Wuerttemberg, Germany
GSK Investigational Site, Rheinstetten, Baden-Wuerttemberg, Germany
GSK Investigational Site, Tauberbischofsheim, Baden-Wuerttemberg, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
GSK Investigational Site, Weilheim, Bayern, Germany
GSK Investigational Site, Wuerzburg, Bayern, Germany
GSK Investigational Site, Frankfurt, Hessen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Wolfenbuettel, Niedersachsen, Germany
GSK Investigational Site, Trier, Rheinland-Pfalz, Germany
GSK Investigational Site, Leipzig, Sachsen, Germany
GSK Investigational Site, Flensburg, Schleswig-Holstein, Germany
GSK Investigational Site, Nordhausen, Thueringen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Hamburg, , Germany
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR