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。为学龄儿童接种疫苗是保护高危人群的一项战略;通过为儿童接种疫苗，可以防止流感传播，并保护并发症高危人群。这项随机临床试验的目的是确定用灭活流感疫苗免疫哈特人聚居区的儿童是否可以预防其他聚居区成员的流感及其并发症。此外，该研究将评估并发症高风险的哈特派的间接受益。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。我们提出了一个设盲的，随机分组对照试验中的哈特殖民地，以测试的假设，即高免疫率（> 70%）的健康儿童与灭活流感疫苗减少流感传播到其他群体成员。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。主要结局将是实验室确认的流感。次要结局包括流感样疾病、中耳炎、医生就诊、抗菌药物处方、缺勤、下呼吸道感染、住院和死亡。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 school-aged children has been proposed as one 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 randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of 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 blinded, 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 other colony members. 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. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death. We believe that the trial we propose will lead to important data that can inform policy on influenza immunization strategy.