tetano
Editor, Senior Moderator
BMJ Open. 2018 Dec 9;8(12):e023118. doi: 10.1136/bmjopen-2018-023118.
[h=1]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.[/h] Caspard H[SUP]1[/SUP], Steffey A[SUP]1[/SUP], Mallory RM[SUP]1[/SUP], Ambrose CS[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] To assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.
[h=4]DESIGN:[/h] Non-interventional cohort study.
[h=4]SETTING:[/h] England during 2013-2014 and 2014-2015 influenza seasons.
[h=4]PARTICIPANTS:[/h] 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.
[h=4]PRIMARY OUTCOME MEASURES:[/h] Primary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
[h=4]TRIAL REGISTRATION NUMBER:[/h] EUPAS18527.
? Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
[h=4]KEYWORDS:[/h] high-risk conditions; hospitalization; live attenuated influenza vaccine; paediatrics; post-licensure safety
PMID: 30530581 DOI: 10.1136/bmjopen-2018-023118
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[h=1]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.[/h] Caspard H[SUP]1[/SUP], Steffey A[SUP]1[/SUP], Mallory RM[SUP]1[/SUP], Ambrose CS[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] To assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.
[h=4]DESIGN:[/h] Non-interventional cohort study.
[h=4]SETTING:[/h] England during 2013-2014 and 2014-2015 influenza seasons.
[h=4]PARTICIPANTS:[/h] 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.
[h=4]PRIMARY OUTCOME MEASURES:[/h] Primary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
[h=4]TRIAL REGISTRATION NUMBER:[/h] EUPAS18527.
? Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
[h=4]KEYWORDS:[/h] high-risk conditions; hospitalization; live attenuated influenza vaccine; paediatrics; post-licensure safety
PMID: 30530581 DOI: 10.1136/bmjopen-2018-023118
Free full text