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2015-2016 年美国儿童中活减毒流感疫苗和灭活流感疫苗的有效性。

2015-2016 Vaccine Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children in the United States.

机构信息

Wake Forest School of Medicine, Winston-Salem, North Carolina.

MedImmune, Gaithersburg, Maryland.

出版信息

Clin Infect Dis. 2018 Feb 10;66(5):665-672. doi: 10.1093/cid/cix869.

Abstract

BACKGROUND

In the 2015-2016 season, quadrivalent live attenuated influenza vaccine (LAIV) and both trivalent and quadrivalent inactivated influenza vaccine (IIV) were available in the United States.

METHODS

This study, conducted according to a test-negative case-control design, enrolled children aged 2-17 years presenting to outpatient settings with fever and respiratory symptoms for <5 days at 8 sites across the United States between 30 November 2015 and 15 April 2016. A nasal swab was obtained for reverse-transcriptase polymerase chain reaction (RT-PCR) testing for influenza, and influenza vaccination was verified in the medical record or vaccine registry. Influenza vaccine effectiveness (VE) was estimated using a logistic regression model.

RESULTS

Of 1012 children retained for analysis, most children (59%) were unvaccinated, 10% received LAIV, and 31% received IIV. Influenza A (predominantly antigenically similar to the A/California/7/2009 strain) was detected in 14% and influenza B (predominantly a B/Victoria lineage) in 10%. For all influenza, VE was 46% (95% confidence interval [CI], 7%-69%) for LAIV and 65% (48%-76%) for IIV. VE against influenza A(H1N1)pdm09 was 50% (95% CI, -2% to 75%) for LAIV and 71% (51%-82%) for IIV. The odds ratio for vaccine failure with RT-PCR-confirmed A(H1N1)pdm09 was 1.71 (95% CI, 0.78-3.73) in LAIV versus IIV recipients.

CONCLUSIONS

LAIV and IIV demonstrated effectiveness against any influenza among children aged 2-17 years in 2015-2016. When compared to all unvaccinated children, VE against influenza A(H1N1)pdm09 was significant for IIV but not LAIV.

CLINICAL TRIALS REGISTRATION

NCT01997450.

摘要

背景

在 2015-2016 赛季,美国可获得四价活流感疫苗(LAIV)和三价及四价灭活流感疫苗(IIV)。

方法

本研究采用病例对照试验设计,于 2015 年 11 月 30 日至 2016 年 4 月 15 日期间,在美国 8 个地点的门诊环境中,纳入了发热并伴有呼吸道症状、病程<5 天的 2-17 岁儿童,采集鼻拭子进行逆转录聚合酶链反应(RT-PCR)检测流感,并在病历或疫苗登记处验证流感疫苗接种情况。采用 logistic 回归模型估计流感疫苗有效性(VE)。

结果

在纳入的 1012 例儿童中,大多数(59%)未接种疫苗,10%接种 LAIV,31%接种 IIV。14%检测到甲型流感(主要与 A/California/7/2009 株具有抗原相似性),10%检测到乙型流感(主要为 B/Victoria 谱系)。对于所有流感,LAIV 的 VE 为 46%(95%置信区间 [CI],7%-69%),IIV 的 VE 为 65%(48%-76%)。LAIV 针对甲型流感(H1N1)pdm09 的 VE 为 50%(95% CI,-2%至 75%),IIV 的 VE 为 71%(51%-82%)。LAIV 与 IIV 相比,RT-PCR 确认为甲型流感(H1N1)pdm09 的疫苗失败的比值比为 1.71(95% CI,0.78-3.73)。

结论

2015-2016 年,LAIV 和 IIV 对 2-17 岁儿童的所有流感均具有有效性。与所有未接种疫苗的儿童相比,IIV 对甲型流感(H1N1)pdm09 的 VE 具有统计学意义,但 LAIV 则不然。

临床试验注册

NCT01997450。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/55d9/5850007/fe2a5326b72a/cix86901.jpg

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