NCT00505453已完成3 期
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
研究概览
简要总结
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.
This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthy male and female adults, 18 years of age and older.
- •Female subject of non-childbearing potential. Written informed consent obtained from subject.
排除标准
- •Acute disease at the time of enrollment.
- •Blood pressure abnormalities.
- •Any immunosuppressive condition, such as HIV or cancer.
- •Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
- •Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
- •Any demyelinating disease, including Guillain-Barré syndrome.
- •Alcohol consumption and/or drug abuse.
- •Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
- •Any known or suspected allergy to the Fluviral vaccine.
结局指标
主要结局
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
时间窗: 21 days after vaccination
次要结局
- Evaluate safety & reactogenicity: Unsolicited AEs(21 days)
- Evaluate safety & reactogenicity: SAEs(entire study)
- Evaluate safety & reactogenicity: Solicited AEs(4 days)
研究者
研究点 (3)
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