At a glance
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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.
In Brief
A Phase 3 clinical trial evaluating Placebo and Cervarix TM for Infections, Papillomavirus. Completed, enrolled 100 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.