Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2–49years

•Q/LAIV is similar to T/LAIV, with an additional influenza B vaccine strain.•62,040 Q/LAIV recipients were enrolled in this prospective observational study.•Rates of events after vaccination were compared versus later in the follow-up.•Rates were also compared versus IIV recipients and unvaccinated...

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Bibliographic Details
Published in:Vaccine 2017-03, Vol.35 (9), p.1254-1258
Main Authors: Baxter, Roger, Eaton, Abigail, Hansen, John, Aukes, Laurie, Caspard, Herve, Ambrose, Christopher S.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Adults
Bells palsy
California - epidemiology
Child
Child, Preschool
Clinical trials
Cohort analysis
Cohort Studies
Confidence intervals
Encephalitis
FDA approval
Female
Guillain-Barre syndrome
Guillain-Barre Syndrome - etiology
Health care
Health services utilization
Hospitalization
Humans
Immunization
Infections
Influenza
Influenza vaccine
Influenza Vaccines - administration & dosage
Influenza Vaccines - adverse effects
Influenza, Human - epidemiology
Influenza, Human - prevention & control
Licenses
Male
Middle Aged
Paediatrics
Post-licensure safety
Prospective Studies
Quadrivalent live attenuated influenza vaccine
Respiratory Sounds - etiology
Vaccination - adverse effects
Vaccines
Vaccines, Attenuated - administration & dosage
Vaccines, Attenuated - adverse effects
Young Adult
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Summary:•Q/LAIV is similar to T/LAIV, with an additional influenza B vaccine strain.•62,040 Q/LAIV recipients were enrolled in this prospective observational study.•Rates of events after vaccination were compared versus later in the follow-up.•Rates were also compared versus IIV recipients and unvaccinated controls.•No safety signal associated with administration of Q/LAIV was observed. 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. 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-Barré 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. 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. 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
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2017.01.062