Influenza Immunization of Children in India

描述（由申请方提供）：研究设计与正在进行的项目相同，但计划了两个主要子目标。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佳的。这项拟议的研究将提供有关疫苗接种时机的数据，这将对热带环境产生广泛影响。具体目标1：描述流感疫苗的直接和间接功效。通过一项前瞻性、对照、家庭随机化、观察者设盲研究确定印度3个农村儿童接种疫苗在减少儿童及其家庭成员流感方面的有效性。建议分为两个阶段：第1阶段：继续确定多个疫苗年对流感的有效性。流感疫苗的效力部分取决于与流行病毒的抗原匹配。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，如果2011年秋季的疫苗接种（根据此处的要求）提供了匹配，则在2012年5月之前进行监测，可以评估秋季接种后2-3年的累积保护效果。此时，第二阶段开始。第2阶段：确定印度北方季风流感高峰前接种疫苗的有效性。在德里地区，流感的最大高峰出现在夏季，冬季出现小高峰。我们假设，在北方印度夏季流感高峰之前的春末接种流感疫苗，与目前秋季接种疫苗方案相比，在流感活动最高期间将提供更好的保护。我们建议测试时间的变化，在2012年5月和2013年免疫接种，随访至2014年5月。这将测量秋季和春季免疫后的直接和间接保护，并延长数据的年份，而不影响研究的总体目标。这种方案可能会导致政策制定者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，是从研究村庄（包括> 16，000人）的每周主动监测中记录的。此外，对其他非流感呼吸道病毒的检测将估计它们对该人群疾病的贡献。总之，拟议的研究将确定用流感病毒疫苗对幼儿进行免疫接种是否不仅能保护免疫儿童，还能保护周围的其他儿童和成人，并将确定印度和其他具有类似流感季节性的地区接种疫苗的适当时机。

DESCRIPTION (provided by applicant): 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.