EUCTR2009-014770-17-NL进行中（未招募）1 期
ew influenza A (H1N1) disease incidence and immunogenicity of the pandemic influenza A (H1N1) vaccine in healthy adults
etherlands Vaccine Institute0 个研究点目标入组 375 人开始时间: 2009年10月23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
- 375
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
- •Subjects have to fulfill all of the following criteria:
- •- age 18 – 52 years
- •- good self-reported health according to the investigator
- •- willingness and ability to adhere to the study regimen
- •- having a signed informed consent (IC) form
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The contra-indications for receiving the pandemic influenza vaccine are exclusion criteria: allergy to any of the components of the vaccine or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
- •The exclusion criteria for blood collection and the immunological analysis are:
- •- immune deficiencies
- •- haematological disorders
- •- bleeding disorders
- •- usage of anticoagulants, corticosteroids, NSAIDs and/or statins
- •- diabetes mellitus
- •- having had an infectious disease with fever within the last two weeks
- •- previously diagnosed with pandemic H1N1 influenza
研究者
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