Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research Datalink

Author:

Caspard Herve,Steffey Amy,Mallory Raburn M,Ambrose Christopher S

Abstract

ObjectivesTo assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.DesignNon-interventional cohort study.SettingEngland during 2013–2014 and 2014–2015 influenza seasons.ParticipantsLAIV 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 outcome measuresPrimary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.Results11 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.ConclusionsThis 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.Trial registration numberEUPAS18527.

Funder

AstraZeneca

Publisher

BMJ

Subject

General Medicine

Reference22 articles.

1. AstraZeneca. Fluenz tetra summary of product characteristics. https://www.medicines.org.uk/emc/medicine/29112 (Accessed 4 Dec 2017).

2. AstraZeneca. Flumist package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM294307.pdf (Accessed 4 Dec 2017).

3. Live Attenuated versus Inactivated Influenza Vaccine in Infants and Young Children

4. Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

5. Nottingham P . Seasonal influenza vaccine uptake reporting specification. http://www.nottingham.ac.uk/primis/documents/specs/seasonal-flu-lqd-specification-14-15-v7.pdf (Accessed 27 Jul 2017).

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3