EUCTR2014-000966-23-NL进行中（未招募）1 期
The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers A pilot proof-of-principle study - Effects of BCG on influenza-induced immune response
Radboud University Nijmegen Medical Centre0 个研究点目标入组 72 人开始时间: 2014年4月9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
- 72
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
- Male
入选标准
- •-Age =18 and =35 yrs or =65 yrs
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •-Prior exposure to ‘Influvac’ influenza virus strains , measured by antibody titres. Previous exposure is defined by antibody titres =1:40.
- •-History of influenza vaccination within the year prior to study entry
- •-History of BCG vaccination within 5 years prior to study entry
- •-History of Mantoux testing within the year prior to study entry
- •-Vaccination other than BCG or influenza, within 3 months prior to study or within study period
- •-Medical history of any disease associated with immune deficiency
- •-Clinically significant acute illness, including infections, within 4 weeks before vaccination
- •-Participation in a drug trial or donation of blood 3 months prior to study entry
- •-Use of recreational drugs within 21 days prior to experiment day
- •-Recent hospital admission or surgery with general anaesthesia (<3 months)
- •-Known chronic kidney or liver disease
- •-Latent or active tuberculosis infection
研究者
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