Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine
研究概览
简要总结
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
- To describe the immune response to study vaccine 21 days after each vaccination.
- To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
- To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
- To describe the safety profiles of study vaccines in all participants.
详细描述
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere [NH] seasonal trivalent influenza vaccine [TIV]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.
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 —（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
To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine
时间窗: 21 days post-vaccination
To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine
时间窗: 0 to7 days post-vaccination and entire study duration
次要结局
未报告次要终点