The safety of inactivated influenza vaccine in adults and children with asthma

M. Castro, A. Dozor, J. Fish, C. Irvin, S. Scharf, M. E. Scheipeter, Janet Teresa Holbrook, James A Tonascia, Robert A Wise

Research output: Contribution to journalArticle

Abstract

Background: Influenza causes substantial morbidity in adults and children with asthma, and vaccination can prevent influenza and its complications. However, there is concern that vaccination may cause exacerbations of asthma. Methods: To investigate the safety of the inactivated trivalent split-virus influenza vaccine in adults and children with asthma, we conducted a multicenter, randomized, double-blind, placebo-controlled, crossover trial in 2032 patients with asthma (age range, 3 to 64 years). The order of injection of vaccine and placebo was assigned randomly, with a mean of 22 days between the injections. Each day during the two weeks after each injection, the patients recorded peak expiratory flow rates, symptoms thought to be related to the injection, use of asthma medications, unscheduled health care visits for asthma, and asthma-related absences from school or work. The primary outcome measure was an exacerbation of asthma in the two weeks after the injections. Results: The frequency of exacerbations of asthma was similar in the two weeks after the influenza vaccination and after placebo injection (28.8 percent and 27.7 percent, respectively; absolute difference, 1.1 percent; 95 percent confidence interval, - 1.4 percent to 3.6 percent). The exacerbation rates were similar in subgroups defined according to age, severity of asthma, and other factors. Among symptoms thought to be associated with the injection, only body aches were more frequent after the vaccine injection than after placebo injection (25.1 percent vs. 20.8 percent, P

Original languageEnglish (US)
Pages (from-to)1529-1536
Number of pages8
JournalNew England Journal of Medicine
Volume345
Issue number21
DOIs
StatePublished - Nov 22 2001
Externally publishedYes

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Inactivated Vaccines
Influenza Vaccines
Asthma
Safety
Injections
Placebos
Human Influenza
Vaccination
Vaccines
Peak Expiratory Flow Rate
Cross-Over Studies
Outcome Assessment (Health Care)
Confidence Intervals
Morbidity
Delivery of Health Care
Pain

ASJC Scopus subject areas

  • Medicine(all)

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The safety of inactivated influenza vaccine in adults and children with asthma. / Castro, M.; Dozor, A.; Fish, J.; Irvin, C.; Scharf, S.; Scheipeter, M. E.; Holbrook, Janet Teresa; Tonascia, James A; Wise, Robert A.

In: New England Journal of Medicine, Vol. 345, No. 21, 22.11.2001, p. 1529-1536.

Research output: Contribution to journalArticle

Castro M, Dozor A, Fish J, Irvin C, Scharf S, Scheipeter ME et al. The safety of inactivated influenza vaccine in adults and children with asthma. New England Journal of Medicine. 2001 Nov 22;345(21):1529-1536. https://doi.org/10.1056/NEJMoa011961
Castro, M. ; Dozor, A. ; Fish, J. ; Irvin, C. ; Scharf, S. ; Scheipeter, M. E. ; Holbrook, Janet Teresa ; Tonascia, James A ; Wise, Robert A. / The safety of inactivated influenza vaccine in adults and children with asthma. In: New England Journal of Medicine. 2001 ; Vol. 345, No. 21. pp. 1529-1536.
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