Dataset from Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine. 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）感染已被明确证实为宫颈癌的核心致病因素。具体而言，部分致癌型别HPV可感染宫颈（子宫的一部分）。该感染可自行消退，但如果持续不愈（即持续性感染），长期可导致女性罹患宫颈癌。本研究将评估葛兰素史克生物制品（GSK Biologicals）HPV-16/18疫苗在研究入组时年龄不超过55岁的女性群体中，12个月随访周期内的免疫原性与安全性。约660名研究受试者将按照0-1-6个月的免疫程序，接受肌内注射该HPV疫苗。本研究将延长随访周期，以进一步评估HPV-16/18疫苗的长期安全性与免疫原性。本研究的方案公示已完成更新，以符合2007年9月颁布的《美国食品药品监督管理局修正案法案》（FDA Amendment Act）。