NCT00697242已完成3 期
Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 4
- 主要终点
- Anti-hepatitis B surface antigen (HBs) antibody concentrations
研究概览
简要总结
In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between 50 and 70 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
排除标准
- •Positive titres for anti hepatitis antibodies
- •Any vaccination against hepatitis B in the past.
- •Any previous administration of MPL
- •Elevated serum liver enzymes at two subsequent determinations 14 days apart.
- •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.
- •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 D
Active Comparator
干预措施: Engerix™-B (Biological)
Group A
Experimental
干预措施: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL (Biological)
Group B
Experimental
干预措施: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL (Biological)
Group C
Experimental
干预措施: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL (Biological)
Group E
Experimental
干预措施: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL (Biological)
结局指标
主要结局
Anti-hepatitis B surface antigen (HBs) antibody concentrations
时间窗: At M2 and M7
次要结局
- Anti-pre-S1 antibody concentrations(Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation)
- Anti-HBs antibody concentrations(Screening, Months 1, 2, 3, 6, 7, 8 and 12)
- Occurrence and intensity of local and general solicited symptoms(4-day after vaccination)
- Cell mediated immunity(Month 0, Month 2 and month 7)
- Occurrence of unsolicited adverse events(30 days after vaccination)
- Occurrence of serious adverse events(During the study period and 30 days after last vaccine dose)
研究者
研究点 (4)
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