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Brief Title: Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) Co-administrated With a Commercially Available Vaccine in Healthy Female Adolescents
Study ID: NCT00652938
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the necessary 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. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.
Detailed Description:
Minimum Age: 9 Years
Eligible Ages: CHILD
Sex: FEMALE
Healthy Volunteers: Yes
GSK Investigational Site, Nijmegen, , Netherlands
GSK Investigational Site, Rotterdam, , Netherlands
GSK Investigational Site, LinkĂśping, , Sweden
GSK Investigational Site, LuleĂĽ, , Sweden
GSK Investigational Site, MalmĂś, , Sweden
GSK Investigational Site, NorrkĂśping, , Sweden
GSK Investigational Site, Skene, , Sweden
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR