EUCTR2010-022372-31-DE进行中（未招募）不适用
An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ Compared with Engerix-B® in Adults With Chronic Kidney Disease Who Have Previously Received a Hepatitis B Vaccine Series - Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End Stage Renal Disease Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 subject must meet all of the following inclusion criteria to participate in the study:
- •1. enrolled and completed a primary hepatitis B series with HEPLISAV or Engerix-B treatment in DV2-HBV-17
- •2. be otherwise clinically stable in the opinion of the investigator
- •3. be able and willing to provide informed consent
- •Are the trial subjects under 18? no
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •A subject who meets any 1 of the following exclusion criteria is not permitted to participate in the study:
- •1. received hepatitis B vaccine off-study after enrolling in DV2-HBV-17
- •2. has a known history of autoimmune disease
- •3. is unwilling or unable to comply with all the requirements of the protocol
研究者
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