NCT00541970

Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 961 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 9 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix	Intramuscular injection, different dosing /schedule
DRUG	Placebo	Intramuscular injection, different dosing /schedule

Timeline

• Start date: 2007-10-17
• Primary completion: 2013-03-18
• Completion: 2013-03-18
• First posted: 2007-10-10
• Last updated: 2018-08-17
• Results posted: 2014-04-17

Locations

25 sites across 2 countries: Canada, Germany