NCT00426361

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

A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 10 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 IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine 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	Boostrix ® Polio	One dose of vaccine administered intramuscularly
BIOLOGICAL	GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)	Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively

Timeline

• Start date: 2007-02-13
• Primary completion: 2008-03-17
• Completion: 2008-07-25
• First posted: 2007-01-24
• Last updated: 2018-07-20
• Results posted: 2010-08-23

Locations

38 sites across 3 countries: France, Germany, Spain