EUCTR2009-016055-22-SE进行中（未招募）不适用
Hepatitis A vaccine in patients with immunomodulative drugs
HY, HUS0 个研究点目标入组 380 人开始时间: 2011年1月11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
- 380
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
- •Diagnosis of rheumatoid arthritis
- •TNF-alfa blocker and / or methotraxate in use as a medication against RA
- •A desire to get protected against hepatitis A
- •Men and women age 18-65 years
- •Written informed consent
- •Women of childbearing potential must use effective contraception
- •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
- •Treatment with rituximab within 9 months before study start
- •Known previous hepatitis A infection
- •Previous vaccination against hepatitis A
- •Egg-, henprotein- or formaldehyde allergy
- •Pregnancy or lactation
- •Excessive use of alcohol
- •An other vaccine given within a month
- •Mentally retardedness
- •Acute disease at the time of examination (fever > 38 degrees)
- •Volunteer works as an employee of the researchers
- •Previous vaccination against hepatitis A
- •Egg-, henprotein- or formaldehyde allergy
- •Pregnancy or lactation
- •Excessive use of alcohol
- •Immunological abnormality: immunosupression or autoimmune disease
- •An other vaccine given within a month
- •Mentally retardedness
- •Acute disease at the time of examination (fever > 38 degrees)
- •Employees of the researchers
- •Not suitable for other reason in the investigator's opinion (other serious disease, i.e. AIDS/HIV-positiv, cancer with ongoing cytostatic treatment)
研究者
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