Prospective Cohort Study of the Influence of Age, Underlying Disease and Immunosuppression on Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,141
- 试验地点
- 2
- 主要终点
- Antibody responses (inhibition of hemagglutination)
研究概览
简要总结
The objective of this study is to assess vaccine responses to novel adjuvanted influenza A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.
详细描述
This prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250 controls to whom influenza A(H1N1) immunization was recommended.
Six cohort have been established, enrolling patients with HIV infection, rheumatic diseases, organ transplant, cancer, pediatric patients and healthy controls.
Subjects will be assessed for specific antibody responses (all), T cell responses (subset) and solicited vaccine adverse events. Vaccine safety evaluation will include the influence of immunization on underlying diseases (HIV infected patients, patients with auto-immune diseases) or graft function (transplant patients) - as appropriate.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •medically recommended influenza A(H1N1) immunization
- •signed informed consent
排除标准
- •failure or refusal to provide sufficient blood for antibody determination
结局指标
主要结局
Antibody responses (inhibition of hemagglutination)
时间窗: 4-6 weeks after immunization
次要结局
- Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)(4-6 weeks after immunization)
- Antibody responses (neutralization)(4-6 weeks after immunization)
- T cell responses(4-6 wks after immunization)