Influenza Immunization of Children in India

7.项目总结 这项研究的设计与正在进行的项目相同，但有两个主要的分目标 有计划的。印度流感的时间循环表明，目前的秋季免疫计划可能 不是最优的。拟议的研究将提供有关疫苗时间的数据，将具有广泛的 在热带环境中的含义。 具体目标1.描述流感疫苗的直接效力和间接效力。通过确定 3个农村儿童接种疫苗对减少儿童及其家庭成员流感的效果 在一项前瞻性、对照、家庭随机、观察者盲法研究中。 建议分两个阶段进行： 阶段1：继续用多个疫苗年确定对流感的疗效。这个 流感疫苗的有效性在一定程度上取决于与流行病毒的抗原匹配。在中国接种疫苗 由于大流行，2009年的匹配率很差，2010年的疫苗接种情况有所改善，如果 2011年秋季(按此处要求)提供匹配，2012年5月之前的监视将提供累积保护 秋季用药后2-3年可评估疗效。此时，第二阶段开始。 第二阶段：确定在#年季风流感高峰期前接种疫苗的效果 印度北部。德里地区的流感高峰期出现在夏季，少数高峰期出现。 在冬天。我们假设，在#年流感高峰期之前，在晚春接种流感疫苗 印度北部的夏季将在高峰期提供明显更好的保护 流感活动，与目前的疫苗接种方案相比，在一年的秋季。我们建议 检测时间发生变化，在2012年5月和2013年5月接种疫苗，随访至2014年5月。这将是 衡量秋季和春季免疫后的直接和间接保护措施，并延长数据年限； 在不影响研究总体目标的情况下。这种养生方式可能会导致政策制定者调整 关于流感疫苗接种时间的建议。 明确目标2.明确流感临床疾病和结局。流感的临床表现， 包括共病情况和流感相关并发症的记录来自每周活动 在由16,000人组成的研究村庄进行监测。此外，对其他非流感病毒进行检测 呼吸道病毒将估计它们在该人群中对疾病的贡献。 综上所述，拟议的研究将确定是否为患有艾滋病的幼儿接种疫苗 流感病毒疫苗不仅能保护接种疫苗的儿童，还能保护其他儿童和 他们周围的成年人，并将确定适当的时间接种疫苗在 印度和其他有类似流感季节性的地区。

7. Project Summary The design of the study remains the same as the ongoing project, however, two major sub-objectives are planned. The temporal circulation of influenza in India suggests the current fall immunization schedule may not be optimal. The proposed study will provide data on vaccine timing that will have broad implications in tropical settings. Specific Aim 1. Describe influenza vaccine direct and indirect efficacy. Accomplished by determining the efficacy of vaccination of children in decreasing influenza in children and their family members in 3 rural villages in India in a prospective, controlled, household randomized, observer blinded study. Two phases are proposed: Phase 1: Continue determination of efficacy against influenza with multiple vaccine years. The efficacy of influenza vaccine depends in part on antigenic match with circulating viruses. Vaccination in 2009 had a poor match due to the pandemic, 2010 vaccination had an improved match and if vaccination in fall 2011 (as requested here) provides a match, with surveillance until May 2012 a cumulative protective effect can be assessed for 2-3 years after fall administration. At this time, phase 2 begins. Phase 2: To determine the efficacy of vaccine administered prior to the monsoon influenza peak in Northern India. The largest peak of influenza is observed in summer in the Delhi region, with minor peaks in winter. We hypothesize that influenza vaccination in late spring prior to the influenza peak in summer in Northern India will confer significantly better protection during the period of highest influenza activity, compared to the current vaccination regimen in the fall of the year. We propose to test a change of timing, immunizing in May 2012 and 2013, with follow-up until May 2014. This will measure direct and indirect protection after both fall and spring immunization and extend the years of data, without compromising the overall objectives of the study. This regimen may lead policy makers to adjust recommendations for the timing of influenza vaccination. Specific Aim 2. Define influenza clinical disease and outcomes. The clinical presentations of influenza, including co-morbid conditions and influenza-related complications are recorded from active weekly surveillance in the study villages comprising >16,000 persons. Furthermore testing for other non-influenza respiratory viruses will estimate their contribution to disease in this population. In summary, the proposed studies will determine whether immunization of young children with influenza virus vaccine protects not only the immunized children but also the other children and adults who are around them, and will identify the appropriate timing of vaccine administration in India and other regions with similar influenza seasonality.