A randomized trial of influenza vaccination of Hutterite children

描述（由申请方提供）：尽管对高风险人群进行了流感免疫接种，但每年的流行病继续对65岁以上人群以及心肺和其他高风险人群的健康构成重大威胁。健康儿童被认为是流感社区传播的重要来源。为健康的学龄儿童接种疫苗已被提议作为保护高危人群的一项战略;通过为儿童接种疫苗，可以预防流感的传播，并保护并发症高危人群。这项计划补助金的目标是制定一项群集随机试验方案，该方案将测试用灭活流感疫苗对哈特人聚居地儿童进行免疫接种的效果，以预防老年人和其他高风险并发症患者的实验室确认流感和其他结果。大多数赫特人生活在阿尔伯塔、萨斯喀彻温和马尼托巴，他们在与城镇隔离的小殖民地从事公共农业。我们提出了一个随机对照试验中的哈特殖民地测试的假设，高免疫率（70%）的健康儿童与灭活流感疫苗减少流感传播的并发症的高风险的人。这些均匀的，中等大小的殖民地的随机化，其中有一个公共的生活方式，促进定期传播，但有限的重新引入，因为相对隔离，从外部社区，代表了一个独特的机会，以测试假设的间接利益接近理想的条件。将在临床试验中评估的结局包括：实验室确认的流感、发热性呼吸道疾病、呼吸道疾病门诊、中耳炎、抗生素处方、学校或工作缺勤住院和死亡。本拟议规划补助金中所述的活动将为开展随机对照试验奠定必要的基础。我们相信，我们提出的试验将产生重要的数据，可以为流感免疫策略的政策提供信息。

DESCRIPTION (provided by applicant): Despite immunization of high risk persons against influenza, annual epidemics continue to pose an important threat to the health of persons over the age of 65 years as well as to persons with cardiopulmonary and other high risk conditions. Healthy children are felt to be an important source for community transmission of influenza. Immunizing healthy school-aged children has been proposed as 1 strategy to protect high risk individuals; by immunizing children spread of influenza is prevented and persons at high risk for complications are protected. The goal of this planning grant is to develop a protocol of a cluster randomized trial which will test the effect of immunizing children in Hutterite colonies with inactivated influenza vaccine in order to prevent laboratory confirmed influenza and other outcomes in older adults and others at high risk for complications. The majority of Hutterites live in Alberta, Saskatchewan, and Manitoba where they practice communal farming on small colonies isolated from towns and cities. We propose a cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates ("70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to persons at high risk of complications. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. Outcomes that will be assessed in the clinical trial include the following: laboratory-confirmed influenza, febrile respiratory illness, office visits for respiratory illness, otitis media, antibiotic prescriptions, school or work absenteeism hospitalizations, and death. The activities described in this proposed planning grant will lay the necessary ground work to conduct the randomized controlled trial. We believe that the trial we propose will lead to important data that can inform policy on influenza immunization strategy.