Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.
研究概览
简要总结
This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.
The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.
详细描述
All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.
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
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.
时间窗: 21 days post-vaccination
次要结局
未报告次要终点