Immunogenicity and Reactogenicity of Trivalent Virosomal Influenza Vaccine Invivac® for the Season 2006/2007. An Open, Baseline-controlled Study in Two Groups of Healthy Subjects: Adults and Elderly.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Invivac® 2006/2007
研究概览
简要总结
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available virosomal vaccine (Invivac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent.
- •Healthy and aged >= 18 and <= 60 years or >= 61 years of age.
- •Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire."
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 (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.
- •Having received vaccination against influenza within the previous six months before Visit
- •Exclusion criteria only for female subjects aged >=18 and <=60 years and of childbearing potential:
- •Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
- •Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
结局指标
主要结局
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Invivac® 2006/2007
次要结局
- HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)