Tags

Type your tag names separated by a space and hit enter

A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 24-59 months of age.
Vaccine. 2013 Apr 03; 31(14):1812-8.V

Abstract

BACKGROUND

In the United States, live attenuated influenza vaccine (LAIV) was initially approved for use in individuals aged 5-49 years in 2003, which was extended to individuals aged 2-49 years in 2007. At that time, a postlicensure commitment was made to describe the safety of LAIV within a cohort of eligible children aged 2-5 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 24-59 months receiving LAIV as part of routine care from October 2007 to March 2010 were compared with rates in a within-cohort self-control, as well as matched unvaccinated and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls. Children with asthma and other high-risk medical conditions before vaccination were excluded. All MAEs and SAEs through 42 days postvaccination and all hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical significance was declared without multiplicity adjustment.

RESULTS

A total of 28,226 unique LAIV recipients were matched with similar numbers of TIV-vaccinated and unvaccinated children. Of 4696 MAE incidence rate comparisons, 83 (1.8%) were statistically significantly higher and 221 (4.7%) 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.

CONCLUSIONS

Results of this postlicensure evaluation of LAIV safety in US children 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 aged 24-59 months who received LAIV.

Authors+Show Affiliations

MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA. Seth.Toback@gilead.comNo 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
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23395734

Citation

Toback, Seth L., et al. "A Postlicensure Evaluation of the Safety of Ann Arbor Strain Live Attenuated Influenza Vaccine in Children 24-59 Months of Age." Vaccine, vol. 31, no. 14, 2013, pp. 1812-8.
Toback SL, Ambrose CS, Eaton A, et al. A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 24-59 months of age. Vaccine. 2013;31(14):1812-8.
Toback, S. L., Ambrose, C. S., Eaton, A., Hansen, J., Aukes, L., Lewis, N., Wu, X., & Baxter, R. (2013). A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 24-59 months of age. Vaccine, 31(14), 1812-8. https://doi.org/10.1016/j.vaccine.2013.01.055
Toback SL, et al. A Postlicensure Evaluation of the Safety of Ann Arbor Strain Live Attenuated Influenza Vaccine in Children 24-59 Months of Age. Vaccine. 2013 Apr 3;31(14):1812-8. PubMed PMID: 23395734.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 24-59 months of age. AU - Toback,Seth L, AU - Ambrose,Christopher S, AU - Eaton,Abigail, AU - Hansen,John, AU - Aukes,Laurie, AU - Lewis,Ned, AU - Wu,Xionghua, AU - Baxter,Roger, Y1 - 2013/02/06/ PY - 2012/10/22/received PY - 2013/01/08/revised PY - 2013/01/25/accepted PY - 2013/2/12/entrez PY - 2013/2/12/pubmed PY - 2014/2/13/medline SP - 1812 EP - 8 JF - Vaccine JO - Vaccine VL - 31 IS - 14 N2 - BACKGROUND: In the United States, live attenuated influenza vaccine (LAIV) was initially approved for use in individuals aged 5-49 years in 2003, which was extended to individuals aged 2-49 years in 2007. At that time, a postlicensure commitment was made to describe the safety of LAIV within a cohort of eligible children aged 2-5 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 24-59 months receiving LAIV as part of routine care from October 2007 to March 2010 were compared with rates in a within-cohort self-control, as well as matched unvaccinated and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls. Children with asthma and other high-risk medical conditions before vaccination were excluded. All MAEs and SAEs through 42 days postvaccination and all hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical significance was declared without multiplicity adjustment. RESULTS: A total of 28,226 unique LAIV recipients were matched with similar numbers of TIV-vaccinated and unvaccinated children. Of 4696 MAE incidence rate comparisons, 83 (1.8%) were statistically significantly higher and 221 (4.7%) 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. CONCLUSIONS: Results of this postlicensure evaluation of LAIV safety in US children 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 aged 24-59 months who received LAIV. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23395734/A_postlicensure_evaluation_of_the_safety_of_Ann_Arbor_strain_live_attenuated_influenza_vaccine_in_children_24_59_months_of_age_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(13)00133-3 DB - PRIME DP - Unbound Medicine ER -