NCT00377585已完成2 期
A Phase II/III, Observer-blind, Multi-Country, Multi-Centre, Randomized Study to Demonstrate the Superiority in Terms of Immunogenicity of Adjuvanted Influenza Vaccine Administered in Adults Aged 50 Years and Older Compared to Fluarix™
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,350
- 试验地点
- 31
- 主要终点
- To demonstrate that the immune response induced by the adjuvanted influenza vaccine in the elderly is superior to that induced by Fluarix, for each vaccine strain
研究概览
简要总结
The study is designed to demonstrate a meaningful difference in immunogenicity between the candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50 years and above.
A control group in younger adults aged 18 to 40 years was included.
详细描述
This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
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
- •The subjects must be healthy adults 18-40 years or >/= 50 years.
排除标准
- •Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, or a licensed vaccine within 2 (inactivated) to 4 (live) weeks before vaccination, if women are pregnant or lactating, or if subjects have acute clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination.
结局指标
主要结局
To demonstrate that the immune response induced by the adjuvanted influenza vaccine in the elderly is superior to that induced by Fluarix, for each vaccine strain
次要结局
- To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix
研究者
研究点 (31)
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