NCT00552279

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. 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	Cervarix TM	Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
BIOLOGICAL	Cervarix TM	Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2007-11-12
• Primary completion: 2009-02-26
• Completion: 2009-07-20
• First posted: 2007-11-01
• Last updated: 2018-06-25
• Results posted: 2010-03-05

Locations

16 sites across 3 countries: Italy, Romania, Slovakia