NCT00652938

Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 744 (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 necessary 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. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV Vaccine (GSK580299) Cervarix TM	IM administration
BIOLOGICAL	Engerix B	IM administration

Timeline

• Start date: 2008-04-09
• Primary completion: 2009-08-28
• Completion: 2010-01-08
• First posted: 2008-04-04
• Last updated: 2018-08-17
• Results posted: 2010-08-31

Locations

7 sites across 2 countries: Netherlands, Sweden