EUCTR2005-004056-13-CZ进行中（未招募）不适用
A phase III, multicentric, multinational, long-term follow-up study to evaluate the persistence of anti-HBs antibodies at Months 12, 24 and 36 in pre-dialysis / peritoneal dialysis or haemodialysis patients who had previously received a primary vaccination course of either Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V or GlaxoSmithKline Biologicals’ Fendrix - HN015/HBVEXT001
适应症
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
- •·Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
- •·Written informed consent obtained from the subject/ from the parent/ guardian of the subject at the first long-term time point that the subject comes back to participate in this study.
- •·Subjects who completed the full course of primary vaccination (three doses of HBV-AS02V vaccine or four doses of Fendrix vaccine) in the study 105757 (HN014/HBV-001) and return at any of the long-term time points (i.e. 12, 24 or 36 months) after the first dose of the primary vaccination.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- •·Any confirmed or suspected human immunodeficiency virus (HIV) infection.
研究者
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