Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Anti-hepatitis B surface antigen (HBs) antibody concentrations
研究概览
简要总结
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 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
- Double
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
- •Positive titres for anti hepatitis B antibodies.
- •Any vaccination against hepatitis B in the past.
- •Elevated serum liver enzymes.
- •History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- •Axillary temperature > 37°C at the time of injection.
- •Any acute disease at the moment of entry.
- •Chronic alcohol consumption.
- •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.
- •Administration of any other vaccine(s) or any immunoglobulin during the study period.
- •Simultaneous participation in any other clinical trial.
研究组 & 干预措施
Group A
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
干预措施: HBV-MPL vaccine (Biological)
Group B
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: Engerix™-B (Biological)
Group B
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: HBV-MPL vaccine (Biological)
Group C
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
干预措施: Engerix™-B (Biological)
Group D
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: Engerix™-B (Biological)
Group D
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: HBV-MPL vaccine (Biological)
Group E
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
干预措施: HBV-MPL vaccine (Biological)
Group F
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: Engerix™-B (Biological)
Group F
Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: HBV-MPL vaccine (Biological)
Group G
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
干预措施: Engerix™-B (Biological)
Group H
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: Engerix™-B (Biological)
Group H
Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
干预措施: HBV-MPL vaccine (Biological)
结局指标
主要结局
Anti-hepatitis B surface antigen (HBs) antibody concentrations
时间窗: One month after the full primary vaccination course and one month after the booster vaccination at 70 months
次要结局
- Serious adverse experiences (SAE).(Throughout the study period)
- Incidence of unsolicited symptoms(During the 30-day follow-up after vaccination)
- Anti-HBs antibody concentrations(Months 1, 2, 3, 6, 12, 13, 42)
- Occurrence, intensity and relationship of solicited general symptoms(8-day follow-up after vaccination)
- Occurrence and intensity of solicited local symptoms(8-day follow-up after vaccination)