NCT00383227已完成3 期
A Phase III, Clinical Trial Comparing the Immunogenicity and Safety of SmithKline Beecham Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-haemodialysis/Haemodialysis Patients (>=15 Years of Age)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- Anti-HBs seroprotection rates at Month 7.
研究概览
简要总结
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female > = 15 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject/ from the parents or guardians of the subject.
- •Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
- •If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
- •Pre-haemodialysis patient* or a patient on haemodialysis.
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
- •Previous vaccination against hepatitis B.
- •History of hepatitis B infection.
- •Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
- •Clinically abnormal ALT/AST values (> 3 times normal values)
结局指标
主要结局
Anti-HBs seroprotection rates at Month 7.
次要结局
- Solicited symptoms, unsolicited symptoms and serious adverse events
研究者
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