EUCTR2007-000875-40-BE进行中（未招募）1 期
Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2007/2008. An open, baseline-controlled multi-centre study in two groups of healthy subjects: Adult subjects aged greater than or equal to 18 and less than or equal to 60 years and elderly subjects greater than 61 years of age. - Influvac Annual Update 2007/2008
Solvay Pharmaceuticals B.V.0 个研究点目标入组 120 人开始时间: 2007年5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
- 120
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
- •1. Signed and dated informed consent.
- •2. Healthy and aged greater than or equal to 18 and less than or equal to 60 years or greater than or equal to 61 years of age.
- •3. Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.
- •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
- •1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- •2. Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
- •3. Having experienced a serious systemic and/or local reaction after previous influenza vaccination.
- •4. Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
- •5. Having received vaccination against influenza within the previous six months before Visit 1.
- •6. Being confined by order of either judicial or administrative authorities.
- •Exclusion criteria only for female subjects aged greater than or equal to 18 and less than or equal to 60 years and of childbearing potential:
- •7. Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
- •8. Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
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