Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2009/2010. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
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 vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: 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
- •Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- •Men and women aged >= 18 and <= 60 years or >= 61 years of age at the day of study vaccination.
- •Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
排除标准
- •Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- •A serious adverse reaction after a previous (influenza) vaccination.
- •Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- •Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
- •A history of Guillain-Barré syndrome or active neurological disease.
结局指标
主要结局
HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
时间窗: 2 weeks
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
时间窗: 3 weeks
次要结局
未报告次要终点