NCT00697775已完成2 期
Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Occurrence of Serious adverse experiences (SAE)
研究概览
简要总结
In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15
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
- None
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: between 11 and 15 years at the time of the first vaccination.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
- •If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- •Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
- •Previous vaccination against hepatitis B virus.
- •Previous vaccination with vaccine containing MPL.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrollment.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Axillary temperature of ≥ 37.5° C.
- •Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •History of chronic disease deemed by the investigator to be relevant.
- •Positive for anti-HBV antibodies at screening
结局指标
主要结局
Occurrence of Serious adverse experiences (SAE)
时间窗: During the study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
时间窗: During the 8-day follow-up period after vaccination
Occurrence, intensity and causal relationship of unsolicited adverse events
时间窗: 31-day follow-up period after vaccination
次要结局
- Anti-HBs antibody concentrations(At months 1, 2, 6, and 7)
- Cell mediated immunity(At months 1, 6, and 7)
研究者
研究点 (1)
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