Department of Medical Affairs, MedImmune/AstraZeneca, Gaithersburg, Maryland, USA.
BMJ Open. 2018 Dec 9;8(12):e023118. doi: 10.1136/bmjopen-2018-023118.
To assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.
Non-interventional cohort study.
England during 2013-2014 and 2014-2015 influenza seasons.
LAIV recipients identified from the Clinical Practice Research Datalink, aged 2-17 years, and with at least one underlying high-risk condition. LAIV recipients were matched with inactivated influenza vaccine (IIV) recipients and unvaccinated controls.
Primary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.
11 463 children and adolescents were included: 4718 received the trivalent LAIV formulation during the 2013-2014 influenza season and 6745 received the quadrivalent formulation during the 2014-2015 influenza season. The risks of hospitalisation within 42 days were 231 per 1000 person-years (95% CI 193 to 275) in season 2013-2014 and 231 (95% CI 198 to 267) in season 2014-2015. These risks were not significantly different when compared with matched unvaccinated children (relative risks (RR) 0.96 (95% CI 0.78 to 1.19) in season 2013-2014, 0.90 (95% CI 0.76 to 1.07) in season 2014-2015) and consistently lower than after IIV administration (RR 0.47 (95% CI: 0.37 to 0.59) in season 2013-2014, 0.42 (95% CI 0.35 to 0.51) in season 2014-2015). A similar pattern was observed up to 6 months postvaccination with a risk of hospitalisation after LAIV administration that did not differ from what was observed in unvaccinated controls and was lower than after IIV administration.
This study did not identify new safety concerns associated with the administration of LAIV in children and adolescents with high-risk conditions. However, as with any other observational study, treatment administration was not randomly assigned and our findings may be confounded by differences between the groups at baseline.
EUPAS18527.
评估高风险人群儿童中使用减毒活流感疫苗（LAIV）的安全性。
非干预性队列研究。
2013-2014 年和 2014-2015 年流感季节的英国。
从临床实践研究数据库中确定的年龄在 2-17 岁且至少有一种潜在高危疾病的 LAIV 受种者。LAIV 受种者与灭活流感疫苗（IIV）受种者和未接种疫苗的对照者相匹配。
主要安全性终点是在接种后 42 天内和接种后长达 6 个月内记录在链接的医院发病统计数据库中的任何住院治疗。
共纳入 11463 名儿童和青少年：4718 名在 2013-2014 年流感季节接种三价 LAIV 制剂，6745 名在 2014-2015 年流感季节接种四价制剂。2013-2014 年季节中，42 天内住院的风险为每 1000 人年 231 例（95%CI193 至 275），2014-2015 年季节中为 231 例（95%CI198 至 267）。与匹配的未接种疫苗儿童相比，这些风险无显著差异（2013-2014 年季节的相对风险（RR）为 0.96（95%CI0.78 至 1.19），2014-2015 年季节为 0.90（95%CI0.76 至 1.07）），且始终低于 IIV 给药后（2013-2014 年季节为 0.47（95%CI：0.37 至 0.59），2014-2015 年季节为 0.42（95%CI0.35 至 0.51））。在接种后长达 6 个月时，也观察到了类似的模式，LAIV 给药后的住院风险与未接种疫苗的对照组相似，且低于 IIV 给药后。
本研究未发现与高风险人群儿童使用 LAIV 相关的新安全性问题。然而，与任何其他观察性研究一样，治疗给药并非随机分配，我们的研究结果可能因基线时各组之间的差异而受到影响。
EUPAS18527。
