Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 798
- 试验地点
- 9
- 主要终点
- Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
研究概览
简要总结
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject prior to enrolment.
- •Subject must have a negative urine pregnancy test.
- •Healthy subject before entering the study entry as established by medical history and physical examination.
- •Subject must be of non-childbearing potential.
排除标准
- •pregnant or breastfeeding subject.
- •previous vaccination against human papillomavirus (HPV).
- •Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
- •History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
结局指标
主要结局
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
时间窗: At Month 7
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
时间窗: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay \[ELISA\] units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
次要结局
- Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18(At Month 2)
- Number of Subjects With New Onset Chronic Diseases (NOCDs)(From Month 0 to Month 7)
- Number of Subjects With Medically Significant Adverse Events (MSAEs)(From Month 0 to Month 7)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Day 0-29) post vaccination)
- Number of Subjects With MSAEs(From Month 0 to Month 12)
- Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18(At Month 2)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-days (Day 0-6) post-vaccination)
- Number of Subjects With (NOCDs)(From Month 0 to Month 12)
- Number of Subjects With Serious Adverse Events (SAEs)(From Month 0 to Month 12)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-days (Day 0-6) post-vaccination)