EUCTR2014-004013-85-DE进行中（未招募）1 期
Sequential versus simultaneous vaccination with pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPV23) in unvaccinated older adults: Immunological memory and antibody levels - SimVac
Friedrich Schiller University Jena0 个研究点目标入组 132 人开始时间: 2015年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- •male and female adults aged 60 years
- •written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 132
排除标准
- •Hypersensitivity to any component of the vaccine
- •prior pneumococcal vaccination
- •Pneumonia in the last 2 months
- •active infection
- •autoimmune disorder (e.g. lupus erythematodes,Wegener's granulomatosis)
- •ongoing or planned immunosuppressive therapy (with corticosteroid therapy from a prednisolone equivalent dose = 5 mg /d)
- •active tumor disease
- •drug or alcohol abuse, or estimate other diseases that do not allow the person concerned, the nature and scope and possible consequences of the trial, incl. non-cooperation
- •expectancy of life < 2 years
- •receive blood products in the last six month
- •all states which represent a contraindication to intramuscular administration of vaccines
- •blood coagulation disorders (e.g. haemophilia, use of oral anticoagulation ,current thrombolytic therapy )
- •incineration, injury or infection at the planned injection position
- •Plegie or paresis of the extremities at the planned injection position
- •states of shock
- •parallel participation in another clinical trial with intervention
研究者
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