NCT00562237终止1 期
Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Surface Antigen Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Hemagglutination inhibition titers
研究概览
简要总结
Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being healthy and ≥ 18 and ≤ 49 years of age
- •willing and able to give informed consent
排除标准
- •having participated in an influenza H5 vaccine trial in the past
- •known to be allergic to any constituent of the vaccine
- •serious adverse reactions to previous (influenza) vaccination
- •currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study
- •using medication that influences the immune system
结局指标
主要结局
Hemagglutination inhibition titers
时间窗: one year
次要结局
- Virus neutralization(one year)
- CHMP criteria(one year)
- Anti-HA antibody level kinetics(one year)
- Safety(one year)
研究者
研究点 (6)
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