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Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years.
Vaccine. 2017 03 01; 35(9):1254-1258.V

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01985997.

Authors+Show Affiliations

Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, Ordway Building, 16th Floor, Oakland, CA 94612, United States.Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, Ordway Building, 16th Floor, Oakland, CA 94612, United States.Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, Ordway Building, 16th Floor, Oakland, CA 94612, United States. Electronic address: john.hansen@kp.org.Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, Ordway Building, 16th Floor, Oakland, CA 94612, United States.AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, United States.AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, United States.

Pub Type(s)

Clinical Trial
Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28162825

Citation

Baxter, Roger, et al. "Safety of Quadrivalent Live Attenuated Influenza Vaccine in Subjects Aged 2-49years." Vaccine, vol. 35, no. 9, 2017, pp. 1254-1258.
Baxter R, Eaton A, Hansen J, et al. Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. Vaccine. 2017;35(9):1254-1258.
Baxter, R., Eaton, A., Hansen, J., Aukes, L., Caspard, H., & Ambrose, C. S. (2017). Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. Vaccine, 35(9), 1254-1258. https://doi.org/10.1016/j.vaccine.2017.01.062
Baxter R, et al. Safety of Quadrivalent Live Attenuated Influenza Vaccine in Subjects Aged 2-49years. Vaccine. 2017 03 1;35(9):1254-1258. PubMed PMID: 28162825.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. AU - Baxter,Roger, AU - Eaton,Abigail, AU - Hansen,John, AU - Aukes,Laurie, AU - Caspard,Herve, AU - Ambrose,Christopher S, Y1 - 2017/02/02/ PY - 2016/09/14/received PY - 2017/01/20/revised PY - 2017/01/21/accepted PY - 2017/2/7/pubmed PY - 2017/12/16/medline PY - 2017/2/7/entrez KW - Adults KW - Influenza vaccine KW - Paediatrics KW - Post-licensure safety KW - Quadrivalent live attenuated influenza vaccine SP - 1254 EP - 1258 JF - Vaccine JO - Vaccine VL - 35 IS - 9 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01985997. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/28162825/Safety_of_quadrivalent_live_attenuated_influenza_vaccine_in_subjects_aged_2_49years_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(17)30128-7 DB - PRIME DP - Unbound Medicine ER -