EUCTR2005-003791-38-DE进行中（未招募）不适用
Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2005/2006. An open, baseline controlled study in twogroups of healthy subjects: adult subjects aged = 18 and =60 years and elderly subjects = 61 years of age.(Extension to protocol S206.3.010) - Invivac
Solvay Pharmaceuticals B.V.0 个研究点目标入组 120 人开始时间: 2005年8月17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
- 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
- •-Signed and dated informed consent
- •-Healthy subjects aged = 18 and = 60 years or = 61 years of age
- •-The mental health of the subject must be 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
- •-Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine
- •-Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways
- •-Having experienced a documented serious systemic reaction after previous influenza vaccination
- •-Having an auto-immune disorder (RA, SLE, auto-immune thyroid disorders), taking immunosuppressive medication (such as corticosteroids) or having a disease in a terminal stage.
- •-Having received vaccination against influenza within the previous six months before Visit 1.
- •Exclusion criteria only for female subjects aged =18 and =60 years:
- •-Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding
- •-For women of childbearing potential: absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
研究者
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