NCT00697749已完成3 期
Phase III Study to Compare Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Adminstered Intramuscularly, According to a 0, 6 Month Schedule, to Engerix™-B 20 mcg Administered According to a 0,1,6 Month Schedule in Healthy Volunteers Positive for the HLA-DQ2 Genotype
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female ≥ 15 years of age 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 subject/ from the parents or guardians of the subject.
- •Known to be seronegative for anti-HBs-antibodies, anti-HBc-antibodies and/or HBsAg.
- •Positive for the HLA-DQ2 genotype as determined in the previous sero-HBV-069 prevalence study.
- •If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
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.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- •Previous vaccination against hepatitis B.
- •History of non-response to previous hepatitis B vaccination.
- •Known exposure to hepatitis B within 6 weeks.
- •History of hepatitis B infection.
- •Confirmed human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •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.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- •Pregnant or lactating female
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: At month 7
次要结局
- Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)(During the study period)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms(During a 30 day follow-up period after each vaccination)
- Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms(During a 4 day follow-up period after each vaccination)
- Cell mediated immunity(At Months 0 and 7)
- Anti-HBs antibody concentrations(Day 0, Month 1, Month 6 and Month 7)
研究者
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