Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 6
- 主要终点
- Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)
研究概览
简要总结
Evaluation of the immunogenicity and reactogenicity of two different formulations of commercially avail-able influenza vaccines in 4 different groups of immunocompromized outpatients (HIV positive patients, patients suffering from rheumatologic diseases and receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in immunocompromized patients in comparison to an older subunit formulation.
详细描述
The infection with influenza is associated with higher morbidity and mortality in risk groups including immunocompromized patients. The virosomal influenza vaccines have been associated with improved immunogenicity in former trials. No direct comparison with older formulations has been conducted so far.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients treated at the Inselspital Bern for:
- •HIV infection
- •rheumatologic diseases and receiving immunosuppressive drugs
- •kidney transplant recipients
- •undergoing hemodialysis or continuous ambulatory peritoneal dialysis
- •written informed consent
排除标准
- •Allergy to egg proteins
- •Former adverse reactions to prior vaccination
- •Febrile conditions at the time of study inclusion
结局指标
主要结局
Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)
时间窗: >60 Wochen
次要结局
- Reactogenicity in rheumatologic patients by disease specific scores(Six weeks after vaccination)
- Immediate side effects at time of application of vaccination(Minutes after vaccination)
- Side effects after vaccination(First week after vaccination)