NCT00718146已完成2 期
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
适应症
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
- Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).
研究概览
简要总结
This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP)
Objectives:
- To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96.
- To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.
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
结局指标
主要结局
Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).
时间窗: 21 days post vaccination
次要结局
未报告次要终点
研究者
研究点 (2)
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