Live attenuated versus inactivated influenza vaccine in infants and young children
Live attenuated versus inactivated influenza vaccine in infants and young children
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DOI：
10.1056/nejmoa065368
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发表时间：
2007-02-15
影响因子：
158.5
通讯作者：
Connor, Edward M.
中科院分区：
文献类型：
--
作者：
Belshe, Robert B.;Edwards, Kathryn M.;Connor, Edward M.
背景美国咨询机构最近建议对 6 至 59 个月大的儿童普遍接种三价灭活流感疫苗。为了评估替代疫苗方法，我们比较了婴幼儿鼻内注射减毒活疫苗与灭活疫苗的安全性和有效性。 方法将 6 至 59 个月大、近期没有哮喘病或严重哮喘发作的儿童按 1:1 的比例随机分配接受冷适应三价减毒活流感疫苗 以双盲方式接种疫苗（鼻内注射流感减毒活疫苗的冷藏稳定制剂）或三价灭活疫苗。在 2004-2005 年流感季节，通过培养物监测流感样疾病。 结果 8352 名儿童获得了安全数据，7852 名儿童根据方案完成了研究。接种减毒活疫苗的组中经培养确诊的流感病例比接种灭活疫苗的组少 54.9%（153 例 vs. 338 例，P
BACKGROUNDUniversal vaccination of children 6 to 59 months of age with trivalent inactivated influenza vaccine has recently been recommended by U.S. advisory bodies. To evaluate alternative vaccine approaches, we compared the safety and efficacy of intranasally administered live attenuated influenza vaccine with those of inactivated vaccine in infants and young children.METHODSChildren 6 to 59 months of age, without a recent episode of wheezing illness or severe asthma, were randomly assigned in a 1:1 ratio to receive either cold-adapted trivalent live attenuated influenza vaccine (a refrigeration-stable formulation of live attenuated intranasally administered influenza vaccine) or trivalent inactivated vaccine in a double-blind manner. Influenza-like illness was monitored with cultures throughout the 2004-2005 influenza season.RESULTSSafety data were available for 8352 children, and 7852 children completed the study according to the protocol. There were 54.9% fewer cases of cultured-confirmed influenza in the group that received live attenuated vaccine than in the group that received inactivated vaccine (153 vs. 338 cases, P