NCT00696891已完成3 期
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 3
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 50 to 70 years old.
- •Good physical condition as established by clinical examination and history taking at the time of entry.
- •Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
- •Written informed consent obtained from the subjects
排除标准
- •Positive at screening for anti-HBV antibodies.
- •Elevated serum liver enzymes
- •History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- •Any acute disease at the moment of entry.
- •Chronic alcohol consumption.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
- •History of allergic disease likely to be stimulated by any component of the vaccine.
- •Simultaneous participation in any other clinical trial.
- •Previous vaccination with a recombinant hepatitis B vaccine.
- •Previous vaccination with an MPL containing vaccine.
- •Administration of immunoglobulins in the past 6 months and during the whole study period
- •Vaccination one week before and one week after each dose of the study vaccine
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At Month 7
次要结局
- Anti-HBs antibody concentrations(At Months 1, 2, 6, 7 and 12)
- Occurrence and intensity of solicited local symptoms(4-day follow-up after vaccination)
- Occurrence and intensity and relationship to vaccination of solicited general symptoms(4-day follow-up after vaccination)
- Occurrence and intensity of any symptoms (solicited/ unsolicited).(4-day follow-up after vaccination)
- Occurrence, intensity and causal relationship of unsolicited symptoms(Within 30 days after vaccination)
- Serious adverse events(Throughout study period)
研究者
研究点 (3)
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