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Brief Title: Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Official Title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
Study ID: NCT00578227
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ÂŽ) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
Detailed Description:
Minimum Age: 9 Years
Eligible Ages: CHILD
Sex: FEMALE
Healthy Volunteers: Yes
GSK Investigational Site, Surrey, British Columbia, Canada
GSK Investigational Site, Brampton, Ontario, Canada
GSK Investigational Site, Newmarket, Ontario, Canada
GSK Investigational Site, Sarnia, Ontario, Canada
GSK Investigational Site, Sudbury, Ontario, Canada
GSK Investigational Site, Hoersholm, , Denmark
GSK Investigational Site, Odense C, , Denmark
GSK Investigational Site, BordĂĄny, , Hungary
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, GyĹr, , Hungary
GSK Investigational Site, HĂłdmezĹvĂĄsĂĄrhely, , Hungary
GSK Investigational Site, Szeged, , Hungary
GSK Investigational Site, Szombathely, , Hungary
GSK Investigational Site, Karlskrona, , Sweden
GSK Investigational Site, LinkĂśping, , Sweden
GSK Investigational Site, Lycksele, , Sweden
GSK Investigational Site, UmeĂĽ, , Sweden
GSK Investigational Site, Ărebro, , Sweden
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR