NCT00697216已完成3 期
Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.
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
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: between 15 and 40 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 aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.
排除标准
- •Positive titres at screening for anti-HBs 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 hepatitis B vaccine.
- •Previous vaccination with an MPL containing vaccine.
- •Administration of immunoglobulins in the past 6 months and during the whole study period
- •Simultaneous vaccination one week before and one week after each dose of the study vaccine
研究组 & 干预措施
Group B
Active Comparator
干预措施: Engerix™-B (Biological)
Group A
Experimental
干预措施: HBV-MPL vaccine 208129 (Biological)
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: Month 7
次要结局
- Anti-HBs antibody concentrations(At months 1, 2, 6, 7 and 12)
- Occurrence, intensity and relationship to vaccination of solicited local and general symptoms(4-day follow-up period after vaccination)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms(31-day follow-up after vaccination)
- Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)(During the study period)
研究者
研究点 (2)
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