A randomized trial of influenza vaccination of Hutterite children

描述（由申请人提供）：尽管对高危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疾病和其他高危疾病患者的健康构成重大威胁。健康儿童被认为是流感社区传播的一个重要来源。对学龄儿童进行免疫接种已被提议作为保护高危人群的一项战略；通过对儿童进行免疫接种，可以预防流感的传播，并保护高危并发症患者。本随机临床试验的目的是确定在huterite菌落中接种灭活流感疫苗的儿童是否可以预防其他菌落成员的流感及其并发症。此外，该研究将评估对高危并发症患者的间接获益。大多数胡特人生活在阿尔伯塔省、萨斯喀彻温省和马尼托巴省，他们在远离城镇的小殖民地上实行集体农业。我们建议在huterite菌落中进行盲法、整群随机对照试验，以验证接种灭活流感疫苗的健康儿童的高免疫接种率（约70%）可减少流感向其他菌落成员传播的假设。对这些同质、中等规模的菌落进行随机化，这些菌落有规律地传播，由于与外部菌落的相对隔离而被限制重新引入，这代表了在接近理想条件下检验间接获益假设的独特机会。主要结果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，我们提议的试验将产生重要的数据，可以为流感免疫战略的政策提供信息。

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.