tetano
Editor, Senior Moderator
Vaccine. 2017 Feb 2. pii: S0264-410X(17)30128-7. doi: 10.1016/j.vaccine.2017.01.062. [Epub ahead of print]
[h=1]Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years.[/h] Baxter R[SUP]1[/SUP], Eaton A[SUP]1[/SUP], Hansen J[SUP]2[/SUP], Aukes L[SUP]1[/SUP], Caspard H[SUP]3[/SUP], Ambrose CS[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Quadrivalent live attenuated influenza vaccine (Q/LAIV) was licensed in 2012 and replaced trivalent live attenuated influenza vaccine in the United States during the 2013-2014 influenza season. This study assessed the safety of Q/LAIV in children and adults aged 2-49years.
[h=4]METHODS:[/h] This was a prospective observational cohort study using data collected from Kaiser Permanente Northern California. Post-vaccination events of interest were any hospitalization, hospitalization for lower respiratory tract infection, and the following medically attended events: hypersensitivity, seizures/convulsions, lower respiratory tract infection, wheezing, Guillain-Barr? syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, and narcolepsy/cataplexy. The rates of these events during the risk interval post-vaccination were compared with rates observed during reference periods later in the follow-up (within-cohort analysis) and with rates observed in frequency-matched unvaccinated controls and inactivated influenza vaccine (IIV) recipients.
[h=4]RESULTS:[/h] A total of 62,040 eligible Q/LAIV recipients were identified during the 2013-2014 influenza season. Within-cohort comparisons of all Q/LAIV recipients as well as comparisons between Q/LAIV recipients and unvaccinated controls or IIV recipients did not show any significantly higher risk of hospitalizations or medically attended events following administration of Q/LAIV. Additional analyses by setting (clinic visits, emergency department visits, and hospital admissions) and age group (2-4, 5-8, 9-17, and 18-49years) also did not reveal clinically consistent findings that suggested any increased risk after administration of Q/LAIV.
[h=4]CONCLUSION:[/h] In this large population study of individuals aged 2-49years, no safety signals associated with the administration of Q/LAIV were observed. A much larger study population would be needed to confidently reject any association between Q/LAIV and very rare events, specifically those with an incidence of <1 event/10,000 person-years.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov NCT01985997.
Copyright ? 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Adults; Influenza vaccine; Paediatrics; Post-licensure safety; Quadrivalent live attenuated influenza vaccine
PMID: 28162825 DOI: 10.1016/j.vaccine.2017.01.062
[PubMed - as supplied by publisher]
[h=1]Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years.[/h] Baxter R[SUP]1[/SUP], Eaton A[SUP]1[/SUP], Hansen J[SUP]2[/SUP], Aukes L[SUP]1[/SUP], Caspard H[SUP]3[/SUP], Ambrose CS[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Quadrivalent live attenuated influenza vaccine (Q/LAIV) was licensed in 2012 and replaced trivalent live attenuated influenza vaccine in the United States during the 2013-2014 influenza season. This study assessed the safety of Q/LAIV in children and adults aged 2-49years.
[h=4]METHODS:[/h] This was a prospective observational cohort study using data collected from Kaiser Permanente Northern California. Post-vaccination events of interest were any hospitalization, hospitalization for lower respiratory tract infection, and the following medically attended events: hypersensitivity, seizures/convulsions, lower respiratory tract infection, wheezing, Guillain-Barr? syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, and narcolepsy/cataplexy. The rates of these events during the risk interval post-vaccination were compared with rates observed during reference periods later in the follow-up (within-cohort analysis) and with rates observed in frequency-matched unvaccinated controls and inactivated influenza vaccine (IIV) recipients.
[h=4]RESULTS:[/h] A total of 62,040 eligible Q/LAIV recipients were identified during the 2013-2014 influenza season. Within-cohort comparisons of all Q/LAIV recipients as well as comparisons between Q/LAIV recipients and unvaccinated controls or IIV recipients did not show any significantly higher risk of hospitalizations or medically attended events following administration of Q/LAIV. Additional analyses by setting (clinic visits, emergency department visits, and hospital admissions) and age group (2-4, 5-8, 9-17, and 18-49years) also did not reveal clinically consistent findings that suggested any increased risk after administration of Q/LAIV.
[h=4]CONCLUSION:[/h] In this large population study of individuals aged 2-49years, no safety signals associated with the administration of Q/LAIV were observed. A much larger study population would be needed to confidently reject any association between Q/LAIV and very rare events, specifically those with an incidence of <1 event/10,000 person-years.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov NCT01985997.
Copyright ? 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Adults; Influenza vaccine; Paediatrics; Post-licensure safety; Quadrivalent live attenuated influenza vaccine
PMID: 28162825 DOI: 10.1016/j.vaccine.2017.01.062
[PubMed - as supplied by publisher]