EUCTR2005-004053-10-HU进行中（未招募）不适用
A phase III, multicentric, multinational, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, administered according to 0, 1, 6 months schedule to that of GlaxoSmithKline Biologicals’ adjuvanted hepatitis B vaccine, Fendrix®, administered according to 0, 1, 2, 6 months schedule, in hepatitis B naïve pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 15 years of age). - HN014/HBV-001
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Henogen
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A male or female subject above or equal to 15 years of age at the time of the first vaccination.
- •Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
- •Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients. Pre-dialysis patient is defined as a patient with a documented creatinine clearance of less or equal to 30ml/min as estimated by the Cockroft-Gault formula.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Use of any registered vaccine within 7 days before the first dose of study vaccine.
- •Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
- •History of hepatitis B infection.
- •Known exposure to hepatitis B virus within 6 months.
- •Use of immunoglobulins within six months preceding the first study vaccination.
- •Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
- •Any confirmed or suspected 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 vaccines.
- •Pregnant or lactating female
研究者
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