A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Henogen
- 入组人数
- 102
- 试验地点
- 46
- 主要终点
- Anti-HBs antibody concentrations
研究概览
简要总结
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives & outcome measures of the extension phase at Months 12, 24 and 36. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).
详细描述
Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
- •Subjects who completed the full course of primary vaccination.
排除标准
- •Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- •Any confirmed or suspected human immunodeficiency virus (HIV) infection.
结局指标
主要结局
Anti-HBs antibody concentrations
时间窗: Months 12, 24 and 36.
次要结局
- Quality of immune response(Month 12, 24 and 36)
- SAEs retrospective reporting(Month 12, 24 and 36)
- RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).(Month 12, 24 and 36)