Study to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 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 present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 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
- 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 HBs antibody.
- •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
干预措施: HBV-MPL 208129 (Biological)
Group B
干预措施: Engerix™-B (Biological)
Group C
干预措施: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation (Biological)
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At month 7
Occurrence and intensity of solicited local and general symptoms
时间窗: 4-day follow-up after vaccination
Occurrence of unsolicited adverse events
时间窗: 30-days after vaccination
Incidence of serious adverse events
时间窗: Throughout the study period
Anti-Hbs antibody concentrations
时间窗: Months 1, 6 and 24
次要结局
未报告次要终点