At a glance
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A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) and Havrix™ for Cervical Intraepithelial Neoplasia and Papillomavirus Infection. Completed, enrolled 1,245 participants across 28 sites in 5 countries.
Detailed Summary
This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit. 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 administrerd intramuscularly according to 0, 1, 6 month schedule
Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.