Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of serious adverse events
研究概览
简要总结
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B
详细描述
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis patients
- •A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- •Age: from 18 years onwards
- •Seronegative for anti- hepatitis antibodies
排除标准
- •History of persistent hepatic, cardiac or respiratory disease
- •Any acute disease at the moment of entry into the study
- •Chronic alcohol consumption
- •Hepatomegaly, right upper quadrant pain or tenderness
- •Any treatment with coticosteroids or immunomodulating drugs
- •Known hypersensitivity to any component of the vaccine
- •Simultaneous participation in any other clinical trial
研究组 & 干预措施
Group A1
Non-responders to vaccination after at least 7 previous injections
干预措施: Engerix™-B (Biological)
Group A2
Non-responders to vaccination after at least 7 previous injections
干预措施: HBV-MPL vaccine 208129 (Biological)
Group B1
Vaccine-responders requiring a booster dose
干预措施: Engerix™-B (Biological)
Group B2
Vaccine-responders requiring a booster dose
干预措施: HBV-MPL vaccine 208129 (Biological)
Group C1
Volunteers participating in the hospital's vaccination program
干预措施: Engerix™-B (Biological)
Group C2
Volunteers participating in the hospital's vaccination program
干预措施: HBV-MPL vaccine 208129 (Biological)
Group D1
Unvaccinated haemodialysis patients
干预措施: Engerix™-B (Biological)
Group D2
Unvaccinated haemodialysis patients
干预措施: HBV-MPL vaccine 208129 (Biological)
结局指标
主要结局
Occurrence of serious adverse events
时间窗: During the course of the study
Occurrence and intensity of solicited local and general symptoms
时间窗: 4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
时间窗: During the course of the study
Anti-HBs antibody concentrations
时间窗: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
次要结局
未报告次要终点