NCT00456807

Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

Complementary Testing to Further Evaluate the Immunogenicity of a GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Aged Over 26 Years Enrolled in Study 104820.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 26 Years
• Healthy volunteers: Accepted

Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites. 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	Placebo	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
BIOLOGICAL	Cervarix TM	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-04-05
• Last updated: 2016-12-16
• Results posted: 2010-07-30

Locations

2 sites across 1 country: Netherlands