Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intramuscular Route)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation.
研究概览
简要总结
This study is in support of the annual application for the variation of the vaccine strains for a marketing authorization.
Objectives:
- To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups, aged 18 to 60 years and aged 61 years or older.
- To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010 formulation in both adult groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older 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
研究组 & 干预措施
Group 1
Participants aged 18 to 60 years at enrollment
干预措施: Influenza virus (split virion, inactivated) vaccine (Biological)
Group 2
Participants aged 61 years or older at enrollment
干预措施: Influenza virus (split virion, inactivated) vaccine (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation.
时间窗: 21 days post-vaccination
To provide information concerning the safety of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation
时间窗: 0 to 7 days post-vaccination and entire study duration
次要结局
未报告次要终点