EUCTR2010-021071-83-HU进行中（未招募）不适用
Tolerability and Immunogenicity Study of FluvalAB Influenza Vaccine (trivalent, seasonal, active ingredient content: 15 µg HA/strain/0.5 mL) in Adults and Elderly Person
Omninvest Ltd.0 个研究点开始时间: 2010年6月18日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Healthy adult volunteers between 18-60 years and over 60 years, both males and females.
- •Full contractual capacity.
- •Negative pregnancy test in case of women with childbearing capacity.
- •Informed consent of the volunteers.
- •Absence of exclusion criteria.
- •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
- •Allergy on egg or on any ingredient of the vaccine.
- •Pregnancy or breast feeding.
- •History of Guillain-Barré syndrome
- •Immunsuppressive therapy in 36 month prior to clinical trial.
- •Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic or renal disease, gongestive heart failure
- •Corticosteroid therapy in progress.
- •Vaccination in 4 weeks prior to clinical trial.
- •Flu vaccination in 6 month prior to clinical trial.
- •Acute disease and/or auxillary temperature >= 37°C within the past 3 days
研究者
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