NCT00434733已完成3 期
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 4,400
- 试验地点
- 1
- 主要终点
- Adverse event rate
研究概览
简要总结
This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects 18 years of age who signed the informed consent
排除标准
- •Receipt of another investigational agent within 4 weeks
- •Receipt of influenza vaccination for current season 2006/
- •any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
- •fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
- •Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
- •Surgery planned during the study period
- •Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
- •Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
- •History of (or current) drug or alcohol abuse
- •Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
结局指标
主要结局
Adverse event rate
次要结局
- Seroconversion and seroprotection after two doses of H5N1 vaccine
研究者
研究点 (1)
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