Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

人乳头瘤病毒（human papillomavirus, HPV）感染已被确凿证实为宫颈癌的核心致病因素。本研究将进一步评估曾参与初始研究（编号580299/001）及随访研究（编号580299/007）的女性受试者的免疫记忆诱导与回忆应答情况。受试者在纳入初始研究时的年龄为15至25岁，随访研究的持续周期约为6年。在初始研究与随访研究阶段，受试者针对HPV-16和HPV-18型别相关临床终点得到了有效保护，且在至少5.5年的随访期内，针对两种疫苗型别均维持了稳定的抗体应答。所有完成随访研究的北美研究站点的受试者，将受邀参与本项研究。本研究将评估一剂葛兰素史克生物制品（GSK Biologicals）HPV疫苗（编号580299）在初始研究中已完成免疫致敏的女性群体中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》。