A randomized trial of influenza vaccination of Hutterite children

说明(申请人提供)：尽管高危人群接种了流感疫苗，但每年的流行病继续对65岁以上的人以及患有心肺和其他高危疾病的人的健康构成重大威胁。健康的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已被提议作为保护高危个人的一项战略；通过为儿童接种疫苗，可防止流感的传播，并保护易患并发症的高危人群。这项随机临床试验的目标是确定用灭活流感疫苗为哈特尔特人殖民地的儿童接种疫苗是否可以预防其他殖民地成员的流感及其并发症。此外，这项研究将评估对并发症风险较高的哈特族人的间接好处。大多数哈特人居住在艾伯塔省、萨斯喀彻温省和马尼托巴省，在那里他们在与城镇隔绝的小殖民地上进行集体耕作。我们建议在哈特尔特人群体中进行一项盲目、整群随机对照试验，以检验这样一种假设，即接种灭活流感疫苗的健康儿童的高免疫率(&gt；70%)可以减少流感向其他群体成员的传播。随机化这些同质的、中等规模的蜂群，在社区生活方式的推动下有规律的传播，但由于与外部社区的相对孤立而重新引入有限，这是在接近理想的条件下检验间接收益假说的独特机会。主要结果将是实验室确认的流感。次要结果包括流感样疾病、中耳炎、就诊、抗菌药物处方、旷工、下呼吸道感染、住院和死亡。我们相信，我们提议的试验将带来重要的数据，可以为流感免疫战略的政策提供参考。

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.