At a glance
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Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
In Brief
A Phase 2 clinical trial evaluating Blood sampling, Collection of cervical specimen, and 1 other intervention for Infections, Papillomavirus. Completed, enrolled 433 participants across 5 sites.
Detailed Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary \& follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
Blood sampling at Visit 3, 5 and 7.
Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.
Three doses administered intramuscularly at 0, 1 and 6 months.