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Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047]

机译:在巴基斯坦卡拉奇的棚户区进行大规模免疫运动的经验教训和启示:一项集群随机化双盲疫苗试验的经验[NCT00125047]

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Objective To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc) will make typhoid fever control become a reality in the near future.
机译:目的确定在巴基斯坦卡拉奇的城市屋居民区的儿科人群中,在当地免疫计划之外实施大规模免疫策略的安全性和后勤可行性。方法2003年8月在60个地理区域进行了一项集群随机双盲预防性试验,覆盖了21,059名2至16岁的儿童。在获得父母或监护人的同意后,合格的儿童在每组疫苗接种站的肠胃外接种Vi多糖或A型肝炎疫苗。安全,物流和标准受到监控并形成文件。结果人群的疫苗覆盖率为74%,在10岁以下的人群中更高。没有报告危及生命的严重不良事件。不良事件的发生率不到所有疫苗接种者的1%,报告的主要反应是发烧和局部疼痛。直到试验结束,密码破裂后,才能知道Vi多糖和A型肝炎患者中不良事件的比例。在整个疫苗接种活动中,维持安全的注射操作,冷链没有中断。贫民窟的大规模疫苗接种得到了很好的接受。由于这些地区的人口流动性强,定居条件可能会影响覆盖范围。全身反应不常见,局部反应轻度和短暂。社区的密切参与对于信息传播和免疫覆盖至关重要。结论描述的这种疫苗策略以及即将在该地区获得的其他信息(成本/效果,疫苗运送成本等)将使伤寒控制在不久的将来成为现实。

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