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。为健康的学龄儿童接种疫苗已被提议作为保护高危人群的1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。这项计划赠款的目标是制定一项分组随机试验的方案，该方案将测试用灭活流感疫苗为哈特利人群体中的儿童接种疫苗的效果，以防止老年人和其他有高并发症风险的人出现实验室确认的流感和其他后果。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Hutterite群体中进行一项整群随机对照试验，以检验以下假设：接种灭活流感疫苗的健康儿童的高免疫率(“70%)可减少流感向并发症高危人群的传播。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。将在临床试验中评估的结果包括：实验室确认的流感、发热性呼吸道疾病、因呼吸道疾病就诊、中耳炎、抗生素处方、旷课或旷工住院和死亡。这项拟议的规划赠款中描述的活动将为进行随机对照试验奠定必要的基础。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 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.