A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,046
- 试验地点
- 4
- 主要终点
- Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
研究概览
简要总结
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 efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cervarix Group
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
干预措施: HPV-16/18 vaccine (Cervarix™) (Biological)
Aimmugen Group
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
干预措施: Aimmugen™ (Biological)
结局指标
主要结局
Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
时间窗: Throughout the study period (up to Month 24)
Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\].
次要结局
- Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection(Up to Month 24)
- Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)(Up to Month 24)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(Within 30 days after any vaccination)
- Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types(Up to Month 24)
- Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types(Up to Month 24)
- Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type(Up to Month 24)
- Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type(Up to Month 24)
- Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value(At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24)
- Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection(Up to Month 24)
- Number of Subjects Reporting Serious Adverse Events (SAE)(Throughout the study period (up to Month 24))
- Outcome of Any Reported Pregnancies(Throughout the study period (up to Month 24))
- Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters(At Month 0 and Month 7)
- Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies(At Months 0, 6, 7, 12, 18 and 24)
- Number of Subjects Reporting Solicited Local and General Symptoms(Within 7 days after each and any vaccination)
- Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters(At Month 0 and Month 7)
- Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)(Throughout the study period (up to Month 24))
- Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples(At Month 0 and Month 7)