NCT00291941已完成3 期
A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Henogen
- 入组人数
- 300
- 试验地点
- 47
- 主要终点
- Anti-HBs seroprotection rate at Month 2.
研究概览
简要总结
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
详细描述
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 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 15 years of age or older at the time of the study entry.
- •Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- •Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
- •Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients.
- •Non-childbearing potential female
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.
- •Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
- •Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic).
- •Pregnant or lactating female
结局指标
主要结局
Anti-HBs seroprotection rate at Month 2.
时间窗: Month 0 and 2
次要结局
- Anti-HBs antibody concentrations(Months 0, 1, 2, 3, 6 and 7)
- Anti-HBs seroprotection rates for all subjects.(Months 0, 1, 2, 3, 6 and 7)
- Anti-HBs seropositivity rates for all subjects(Months 0, 1, 2, 3, 6 and 7)
- Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects.(Months 0, 1, 2, 3, 6 and 7)
- Anti-HBs geometric mean concentrations calculated for all subjects.(Months 0, 1, 2, 3, 6 and 7)
- Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group.(Months 0 and 7)
- Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group.(Month 0 and 7)
- Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall.(Month 0, 1, 2, 3, 6 and 7)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall.(Month 0, 1, 2, 3, 6 and 7)
- Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7.(Month 0 to 7)
研究者
研究点 (47)
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