EUCTR2007-000964-26-IT进行中（未招募）不适用
A Phase II, Open Label, Uncontrolled, Multi-Center Study to support annual strain update and to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Influenza Vaccine, Formulation 2007-2008, when Administered to Subjects aged 18-64 years affected by chronic diseases - ND
OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 个研究点开始时间: 2007年6月7日最近更新:
适应症
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
- •18-64- years of age, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. suffering from at least one of the following chronic diseases: · hypertension · hearth diseases · chronic obstructive pulmonary disease (COPD) or asthma hepatic or renal insufficiency · arteriosclerotic disease or insulin dependent diabetes mellitus
- •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
- •Individuals are not to be enrolled into the study if: 1. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 2. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 3. they have a known or suspected (or have a high risk of developing) impairment/ alteration of immune function resulting, for example, from: · receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and/or for the full length of the study; · suspected or known HIV infection or HIV-related disease women who are pregnant, or women who are breast-feeding, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); 7. within the past 12 months, they have: · received more than one injection of influenza vaccine;
研究者
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