NCT00369824

Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,330 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Different formulations of GSK Biologicals' HPV vaccine (580299)	Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
BIOLOGICAL	Menactra TM	One dose of vaccine administered intramuscularly
BIOLOGICAL	Boostrix TM	One dose of vaccine administered intramuscularly

Timeline

• Start date: 2006-09-26
• Primary completion: 2007-11-22
• Completion: 2008-02-13
• First posted: 2006-08-29
• Last updated: 2018-07-20
• Results posted: 2009-10-08

Locations

50 sites across 1 country: United States