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A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age.
Vaccine. 2012 Apr 19; 30(19):2989-98.V

Abstract

BACKGROUND

Live attenuated influenza vaccine (LAIV) was licensed in 2003 in the United States for use in individuals aged 5-49 years.

METHODS

A prospective observational postmarketing study was conducted to evaluate the safety of LAIV. Rates of medically attended events (MAEs) and serious adverse events (SAEs) in eligible children aged 5-17 years receiving LAIV as part of routine care from October 2003 to March 2008 were compared with rates in nonrandomized self, matched unvaccinated, and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls. All MAEs and SAEs through 42 days postvaccination and all hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical significance was assigned without multiplicity adjustment.

RESULTS

43,702 LAIV recipients were matched with similar numbers of TIV-vaccinated and unvaccinated children. Of approximately 9500 MAE incidence rate comparisons, 204 were statistically significantly higher and 168 were statistically significantly lower in LAIV recipients versus controls. No pattern of MAE rate differences suggested a safety signal with LAIV. Asthma/wheezing MAEs were not statistically increased in LAIV recipients. No anaphylaxis events occurred within 3 days postvaccination. Rates of SAEs were similar between LAIV and control groups. Two SAEs were considered possibly related to LAIV: Bell's palsy and nonspecific paroxysmal spell.

CONCLUSIONS

Results of this postlicensure evaluation of LAIV safety in US children aged 5-17 years are consistent with preapproval clinical studies and Vaccine Adverse Event Reporting System reports, both of which demonstrated no significant increase in asthma/wheezing events or other adverse outcomes among eligible children who received LAIV.

Authors+Show Affiliations

Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. roger.baxter@kp.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22386746

Citation

Baxter, Roger, et al. "A Postmarketing Evaluation of the Safety of Ann Arbor Strain Live Attenuated Influenza Vaccine in Children 5 Through 17 Years of Age." Vaccine, vol. 30, no. 19, 2012, pp. 2989-98.
Baxter R, Toback SL, Sifakis F, et al. A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age. Vaccine. 2012;30(19):2989-98.
Baxter, R., Toback, S. L., Sifakis, F., Hansen, J., Bartlett, J., Aukes, L., Lewis, N., Wu, X., & Ambrose, C. S. (2012). A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age. Vaccine, 30(19), 2989-98. https://doi.org/10.1016/j.vaccine.2012.02.039
Baxter R, et al. A Postmarketing Evaluation of the Safety of Ann Arbor Strain Live Attenuated Influenza Vaccine in Children 5 Through 17 Years of Age. Vaccine. 2012 Apr 19;30(19):2989-98. PubMed PMID: 22386746.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age. AU - Baxter,Roger, AU - Toback,Seth L, AU - Sifakis,Frangiscos, AU - Hansen,John, AU - Bartlett,Joan, AU - Aukes,Laurie, AU - Lewis,Ned, AU - Wu,Xionghua, AU - Ambrose,Christopher S, Y1 - 2012/02/29/ PY - 2011/09/14/received PY - 2012/02/14/revised PY - 2012/02/15/accepted PY - 2012/3/6/entrez PY - 2012/3/6/pubmed PY - 2012/7/28/medline SP - 2989 EP - 98 JF - Vaccine JO - Vaccine VL - 30 IS - 19 N2 - BACKGROUND: Live attenuated influenza vaccine (LAIV) was licensed in 2003 in the United States for use in individuals aged 5-49 years. METHODS: A prospective observational postmarketing study was conducted to evaluate the safety of LAIV. Rates of medically attended events (MAEs) and serious adverse events (SAEs) in eligible children aged 5-17 years receiving LAIV as part of routine care from October 2003 to March 2008 were compared with rates in nonrandomized self, matched unvaccinated, and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls. All MAEs and SAEs through 42 days postvaccination and all hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical significance was assigned without multiplicity adjustment. RESULTS: 43,702 LAIV recipients were matched with similar numbers of TIV-vaccinated and unvaccinated children. Of approximately 9500 MAE incidence rate comparisons, 204 were statistically significantly higher and 168 were statistically significantly lower in LAIV recipients versus controls. No pattern of MAE rate differences suggested a safety signal with LAIV. Asthma/wheezing MAEs were not statistically increased in LAIV recipients. No anaphylaxis events occurred within 3 days postvaccination. Rates of SAEs were similar between LAIV and control groups. Two SAEs were considered possibly related to LAIV: Bell's palsy and nonspecific paroxysmal spell. CONCLUSIONS: Results of this postlicensure evaluation of LAIV safety in US children aged 5-17 years are consistent with preapproval clinical studies and Vaccine Adverse Event Reporting System reports, both of which demonstrated no significant increase in asthma/wheezing events or other adverse outcomes among eligible children who received LAIV. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22386746/A_postmarketing_evaluation_of_the_safety_of_Ann_Arbor_strain_live_attenuated_influenza_vaccine_in_children_5_through_17_years_of_age_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00233-2 DB - PRIME DP - Unbound Medicine ER -