A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 6
- 主要终点
- To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
研究概览
简要总结
This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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, adult and elderly volunteers over 18 years
排除标准
- •Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
研究组 & 干预措施
1
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
干预措施: Seasonal Influenza Vaccine (Biological)
结局指标
主要结局
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
时间窗: 22 days including follow-up period
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
次要结局
未报告次要终点