NCT00697931已完成3 期
Study to Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: older than 18 years of age.
- •Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
- •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
排除标准
- •Positive at screening for anti-HBV 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 an MPL containing vaccine.
- •Administration of immunoglobulins 6 months before and during the whole study period
- •Vaccination one month before and one month after each dose of the study vaccine
研究组 & 干预措施
Group A
Experimental
干预措施: Recombinant MPL- adjuvanted hepatitis B vaccine (Biological)
Group B
Active Comparator
干预措施: Engerix™-B (Biological)
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At month 7
次要结局
- Anti-HBs antibody concentrations(At months 2, 6, 7 and 12)
- Occurrence and intensity of solicited local symptoms(4-day follow-up after vaccination)
- Occurrence, intensity and relationship of solicited general symptoms(4-day follow-up after vaccination)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms(Within 30 days after vaccination)
- Incidence of serious AEs(Throughout the entire study up to and including 30 days after the last vaccination)
- Cell mediated immunity(At months 0, 2, 6, 7, 12)
研究者
研究点 (1)
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