NCT00578227

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 814 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 9 Years – 15 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/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix™	Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
BIOLOGICAL	Twinrix ™ Paediatric	Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Timeline

• Start date: 2007-12-15
• Primary completion: 2008-12-01
• Completion: 2009-04-28
• First posted: 2007-12-21
• Last updated: 2018-08-17
• Results posted: 2010-01-06

Locations

21 sites across 4 countries: Canada, Denmark, Hungary, Sweden