NCT00197301已完成1 期
Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Seroprotection
研究概览
简要总结
Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 20 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young(20-45years old) and elderly(65-95 years old) volunteers -
排除标准
- •Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons
结局指标
主要结局
Seroprotection
次要结局
- Antibody levels
研究者
研究点 (2)
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