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Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age

Infections, Papillomavirus Clinical Trial

Official title:
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.

Clinical Trial Summary

Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. 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, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00492544
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date July 2, 2007
Completion date March 28, 2008
View Details
See also
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