Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
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
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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