NCT00698087已完成3 期
Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 40 years old.
- •Written informed consent will have been obtained from the subjects.
- •Good physical condition as established by physical examination and history taking at the time of entry.
- •Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry
排除标准
- •Pregnancy or lactation.
- •Positive titres for anti hepatitis B antibodies
- •Any vaccination against hepatitis B in the past.
- •Any previous administration of MPL.
- •Elevated serum liver enzymes.
- •History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- •Axillary temperature > 37.5°C at the time of injection.
- •Any acute disease at the moment of entry.
- •Chronic alcohol consumption.
- •Any treatment with immunosuppressive or immunostimulant therapy.
- •Any chronic drug treatment, 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 administration of any other vaccine(s).
- •Administration of any immunoglobulin during the study period.
- •Simultaneous participation in any other clinical trial
研究组 & 干预措施
Group A
Experimental
干预措施: MPL-Adjuvanted recombinant hepatitis B vaccine (Biological)
Group B
Active Comparator
干预措施: Engerix™-B (Biological)
Group C
Experimental
干预措施: MPL-Adjuvanted recombinant hepatitis B vaccine (Biological)
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At M3 and M13
Occurrence of local and general solicited symptoms
时间窗: 4-day follow-up after vaccination
Occurrence of unsolicited symptoms
时间窗: 30-day follow-up after vaccination
次要结局
- Anti-HBs antibody concentrations(Months 2, 3, 6, 9, 12, 13)
- SAEs(Throughout the study up to 30 days after last vaccination)
研究者
研究点 (1)
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