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 Vaccines1 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1日最近更新:
适应症
干预措施
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
- 1
- 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
研究组 & 干预措施
non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen
Experimental
干预措施: MF59 adjuvanted H5N1 influenza vaccine (Biological)
MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms
Experimental
干预措施: MF59 adjuvanted H5N1 influenza vaccine (Biological)
MF59 adjuvant H5N1 influenza vaccine 15 micrograms
Experimental
干预措施: MF59 adjuvanted H5N1 influenza vaccine (Biological)
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 (1)
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