Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
Status:
Completed
Trial end date:
2013-03-18
Target enrollment:
Participant gender:
Summary
Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical
cancer. GlaxoSmithKline (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 this vaccine has been found to be efficacious in the
prevention of incident and persistent HPV-16/18 infections and associated cytological
abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will
evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and
an alternative dosing when administered in healthy young females aged 9 to 25 years, as
compared to the standard HPV vaccine. The Protocol Posting has been updated in order to
comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following
a protocol amendment.