Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls
研究概览
简要总结
Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study.
The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.
详细描述
Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study.
Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined.
The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
- •Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.
结局指标
主要结局
Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls
时间窗: 4 months
次要结局
- Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination(February 2011)