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Brief Title: Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Official Title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Study ID: NCT00877877
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Detailed Description: Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study. Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
GSK Investigational Site, Bogota, , Colombia
GSK Investigational Site, Deggingen, Baden-Wuerttemberg, Germany
GSK Investigational Site, Ettenheim, Baden-Wuerttemberg, Germany
GSK Investigational Site, Kehl, Baden-Wuerttemberg, Germany
GSK Investigational Site, Mannheim, Baden-Wuerttemberg, Germany
GSK Investigational Site, Tauberbischofsheim, Baden-Wuerttemberg, Germany
GSK Investigational Site, Weilheim, Bayern, Germany
GSK Investigational Site, Wuerzburg, Bayern, Germany
GSK Investigational Site, Buetzow, Mecklenburg-Vorpommern, Germany
GSK Investigational Site, Rostock, Mecklenburg-Vorpommern, Germany
GSK Investigational Site, Wolfenbuettel, Niedersachsen, Germany
GSK Investigational Site, Bochum, Nordrhein-Westfalen, Germany
GSK Investigational Site, Willich, Nordrhein-Westfalen, Germany
GSK Investigational Site, Trier, Rheinland-Pfalz, Germany
GSK Investigational Site, Flensburg, Schleswig-Holstein, Germany
GSK Investigational Site, Harrislee, Schleswig-Holstein, Germany
GSK Investigational Site, Niebuell, Schleswig-Holstein, Germany
GSK Investigational Site, Weimar, Thueringen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Tegucigalpa, Francisco Morazan, Honduras
GSK Investigational Site, Arraijan/Vista Alegre, Panamá, Panama
GSK Investigational Site, La Chorrera, , Panama
GSK Investigational Site, Taipei, , Taiwan
GSK Investigational Site, Taoyuan, , Taiwan
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR