NCT00423046

Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age

Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,106 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in \> 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® \[quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine\] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age. The Protocol Posting has been updated as the study will be extended by 3 additional years.

Detailed description

This Protocol Posting has been updated following Protocol Amendment 25, November 2010

Conditions

• Infections, Papillomavirus
• Papillomavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)	Three doses administered intramuscularly at months 0, 1 and 6
BIOLOGICAL	Gardasil ® (Merck & Co. Inc)	Three doses administered intramuscularly at months 0, 2 and 6
BIOLOGICAL	Placebo	One dose administered intramuscularly at month 1 to maintain blinding
BIOLOGICAL	Placebo	One dose administered intramuscularly at month 2 to maintain blinding

Timeline

• Start date: 2007-01-24
• Primary completion: 2008-03-07
• Completion: 2012-05-14
• First posted: 2007-01-17
• Last updated: 2020-01-02
• Results posted: 2010-08-25

Locations

40 sites across 1 country: United States