EUCTR2006-003650-20-IT进行中（未招募）不适用
A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - ND
Merck and Co Inc.0 个研究点目标入组 276 人开始时间: 2007年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
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
- •1. Male and female predialysis patients (defined as having a creatinine clearance <=30 mL/min as calculated according to the Cockroft-Gault formula) or patients currently receiving either hemodialysis or peritoneal dialysis. 2. Visit 1 (screening visit) blood sample with laboratory confirmed negative result for HBsAg, anti-HBc and anti-HBs. 3. At least 18 years of age. 4. For women, a negative urine pregnancy test just prior to vaccination on visit 2 (day 1)
- •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
- •1. History of previous hepatitis B infection. 2. History of vaccination with any hepatitis B vaccine either alone or in combination. 3. Recent (<72 hours) history of febrile illness (oral temperature >=37.8?C/>=100.0?F). 4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (e.g., aluminum, yeast). 5. Recent administration (within 3 months prior to first injection with the study vaccine)of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood derived product or plans to receive such products within the study period. 6. Receipt of licensed inactivated vaccines within 14 days prior to vaccination with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to vaccination with the study vaccine or plans to receive licensed vaccines within 30 days following each dose of study vaccine. 7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or plans to receive investigational drugs or vaccines within the study period. 8. Known or suspected impairment of immunologic function (other than from renal disease) (e.g., HIV positivity, end-stage liver disease). 9. Recent use (within 3 months prior to first injection with the study vaccine) of systemic immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. 10. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. 11. Currently abusing IV drugs. 12. Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
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