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Spots Global Cancer Trial Database for Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 9 Years

Eligible Ages: CHILD

Sex: FEMALE

Healthy Volunteers: Yes

Locations

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, Győr, , Hungary

GSK Investigational Site, Hódmezővásárhely, , 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, Örebro, , Sweden

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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