At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
In Brief
A Phase 3 clinical trial evaluating Cervarix™ and Twinrix ™ Paediatric for Infections, Papillomavirus. Completed, enrolled 814 participants across 21 sites in 4 countries.
Detailed Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
Study Details
Timeline
Interventions
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose