At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Different formulations of GSK Biologicals' HPV vaccine (580299), Menactra TM, and 1 other intervention for Infections, Papillomavirus. Completed, enrolled 1,330 participants across 50 sites.
Detailed 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/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.
Study Details
Timeline
Interventions
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
One dose of vaccine administered intramuscularly
One dose of vaccine administered intramuscularly