Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing

Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

人乳头瘤病毒（Human Papillomavirus, HPV）感染已被证实为宫颈癌发生的必要致病因素。葛兰素史克（GlaxoSmithKline, GSK）生物制品部研发了一款编号为580299的HPV疫苗，该疫苗针对两种最常见的致癌型别HPV-16与HPV-18，这两种型别约占全部宫颈癌病例的70%。既往临床试验已证实，该疫苗可有效预防新发及持续性HPV-16/18感染，以及与之相关的细胞学异常与宫颈上皮内瘤变。在本部分盲法研究中，葛兰素史克生物制品部将针对9至25岁健康年轻女性，对比标准HPV疫苗接种方案，评估该疫苗采用替代接种程序与替代给药剂量时的安全性与免疫原性。本研究方案已完成更新，以符合2007年9月颁布的《FDA修正案（FDA Amendment Act）》，本次更新系因一项方案修正案所致。