Infections, Papillomavirus Clinical Trial
Official title:
Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects
A phase I, open label, single-centre study to evaluate the safety and immunogenicity of
GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM),
administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female
subjects aged 15 - 45 years.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The rationale for the protocol posting amendment was to change the study population from 18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g. Hepatitis A&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis etc. up to 8 days before each HPV dose. ;
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