EUCTR2011-003188-31-IT进行中（未招募）不适用
A Phase IV, open label study to evaluate the immune response against homogenous and heterogenous circulating strains in elderly subjects after vaccination with Inflexal V - CroSSome Study
CRUCELL SWITZERLAND AG0 个研究点开始时间: 2012年1月23日最近更新:
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 female and male adults aged >60 years on the day of enrollment; Written informed consent; Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease; Acute febrile illness (=38.0 °C); Prior vaccination with an influenza vaccine for season 2011/2012; Known hypersensitivity to any vaccine component; Previous history of a serious adverse reaction to influenza vaccine; History of egg protein allergy or severe atopy; Known blood coagulation disorder; Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of =0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed); Known immunodeficiency (including leukemia, HIV seropositivity) or cancer; Investigational medicinal product received in the past 3 months (90 days); Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days); Participation in another clinical trial; Employee at the investigational site or relative of the investigator; Anticipated non-compliance with study procedures.
研究者
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