A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 3
- 主要终点
- Feasibility
研究概览
简要总结
A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.
详细描述
Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. This pilot study will provide needed data to establish the feasibility of a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years and NYHA functional class II, III and IV
排除标准
- •Anaphylactic reaction to a previous dose of TIV
- •Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- •Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
- •Anaphylactic reaction to neomycin
- •Patients who have had influenza vaccine in two of the three previous years
研究组 & 干预措施
influenza vaccine
Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine
干预措施: inactivated trivalent influenza vaccine (Drug)
placebo vaccination
Participants at high risk for adverse vascular events will be immunized with a 0.5 ml dose of sterile saline inactivated during the influenza season.
干预措施: Sterile saline (Other)
结局指标
主要结局
Feasibility
时间窗: Six months
If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up.
次要结局
- Cardiovascular death(Six months)
- Adverse cardiovascular event(Six months)