NCT00291954已完成3 期
A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Henogen
- 入组人数
- 257
- 试验地点
- 49
- 主要终点
- Anti-HBs seroprotection rate
研究概览
简要总结
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
详细描述
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.
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
- 否
入选标准
- •A male or female subject greater than or equal to 15 years of age at the time of study entry
- •Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- •Seronegative for anti-HBc antibodies and for HBsAg at screening.
- •Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
- •Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
- •The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
- •Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.
排除标准
- •Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
- •Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female
结局指标
主要结局
Anti-HBs seroprotection rate
时间窗: Month 2
次要结局
- Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects(Months 0, 1 and 2)
- Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall(Month 0, 1 and 2)
- Anti-HBs Seroprotection rates for all subjects.(Months 0, 1 and 2)
- Anti-HBs Geometric Mean Concentrations calculated for all subjects.(Months 0, 1 and 2)
- Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall(Month 0, 1 and 2)
- Anti-HBs Seropositivity rates for all subjects.(Months 0, 1 and 2)
- Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2(Month 0 to 2)
研究者
研究点 (49)
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