Infections, Papillomavirus Clinical Trial
Official title:
A Randomized, Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine Co-administered Intramuscularly With Boostrix® and/or Menactra™ in Healthy Female Subjects Aged 11-18 Years
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/adolescents
platform. Therefore, this Phase 3b study is designed to evaluate the safety and
immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine
(580299) as compared to the administration of any of the vaccines alone.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
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Phase 3 |