Influenza Immunization of Children in India

7. 项目摘要 研究的设计与正在进行的项目相同，但有两个主要的次级目标 计划好了流感在印度的时间传播表明，目前的秋季免疫接种时间表可能 不是最优的。拟议的研究将提供疫苗接种时间的数据， 在热带地区的影响。 具体目标1。描述流感疫苗的直接和间接效力。通过确定 3个农村地区儿童流感疫苗接种对降低儿童及其家庭成员流行性感冒的效果 在一项前瞻性、对照、家庭随机化、观察员盲法研究中， 建议分两个阶段： 第1阶段：继续确定多个疫苗年对流感的有效性。的 流感疫苗的效力部分取决于与流行病毒的抗原匹配。疫苗接种 由于大流行，2009年的疫苗接种匹配性较差，2010年的疫苗接种匹配性有所改善， 2011年秋季（如此处所要求）提供了一个匹配，直到2012年5月的监视， 秋季用药后2-3年可评价疗效。此时，第二阶段开始。 第2阶段：确定在季风流感高峰期之前接种疫苗的有效性， 印度北方。在德里地区观察到流感的最大高峰在夏季， 冬季我们假设，在春季末流感高峰之前接种流感疫苗， 在印度北方的夏季， 流感活动，与目前的疫苗接种方案相比，在今年秋季。我们建议 测试时间的变化，免疫接种在2012年5月和2013年，随访至2014年5月。这将 在秋季和春季免疫接种后测量直接和间接保护，并延长数据的年份， 不影响研究的总体目标。这一方案可能会导致政策制定者做出调整 流感疫苗接种时间的建议。 具体目标2。定义流感临床疾病和结果。流感的临床表现， 包括合并症和流感相关并发症， 在研究村庄的监测包括> 16，000人。其他非流感病毒检测 呼吸道病毒将估计它们对该人群疾病的贡献。 总之，拟议的研究将确定是否免疫幼儿与 流感病毒疫苗不仅保护免疫儿童，而且保护其他儿童， 他们周围的成年人，并将确定适当的疫苗接种时间， 印度等流感季节性相似的地区。

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.