NCT00382187已完成2 期
A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults
Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年11月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
研究概览
简要总结
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers 18-60 years of age
排除标准
- •Any auto-immune disease or other serious acute, chronic or progressive disease
- •Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
- •History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- •Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy
结局指标
主要结局
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
时间窗: day 1 to day 43
次要结局
- Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.(Day 1 to Day 382)
研究者
研究点 (2)
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