NCT01003288已完成不适用
Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Number of Participants With Local and Systemic Adverse Events
研究概览
简要总结
Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects
详细描述
The investigators will conduct a safety and immunogenicity study in health employees as detailed below:
- Examine adverse events of all employees after vaccination using adverse events form
- Examine the immunogenicity of the vaccine by collecting blood samples at days 0, 21 & 42 after vaccination (up to 500 people)
- Provide a detailed time course of the immune response to vaccination with a novel influenza H1N1 virus including the kinetics of the T-cell, B-cell and antibody responses in 50 volunteers
- Investigate the long lasting immunity induced by the vaccine
- Examine the ability of the vaccine to induce cross-reactive immunity to H1N1 strains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits for the kinetic study
排除标准
- •Persons with a history of anaphylaxis or serious reactions to any vaccine
- •Person with known hypersensitivity to any of the vaccine components
- •Persons who have had a temperature >38oC during the previous 72 hours
- •Persons who have had an acute respiratory infection during the last 7 days
- •Suspected non-compliance
结局指标
主要结局
Number of Participants With Local and Systemic Adverse Events
时间窗: 21 days after vaccination
Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.
次要结局
- Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay(7, 14, 21 days post vaccination and long term follow up for 5 years)
研究者
Rebecca Cox
Professor
University of Bergen
研究点 (2)
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