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Randomized Controlled Trial
. 2022 Apr 1;149(4):e2021055432.
doi: 10.1542/peds.2021-055432.

Safety of Live Attenuated Influenza Vaccine in Children With Asthma

Andrew G Sokolow #  1   2 , Amy P Stallings #  3   4 , Carolyn Kercsmar  5 , Theresa Harrington  6 , Natalia Jimenez-Truque  7 , Yuwei Zhu  8 , Katherine Sokolow  2   7 , M Anthony Moody  4   9 , Elizabeth P Schlaudecker  5 , Emmanuel B Walter  4   9 , Mary Allen Staat  5 , Karen R Broder  6 , C Buddy Creech  7
Affiliations
Randomized Controlled Trial

Safety of Live Attenuated Influenza Vaccine in Children With Asthma

Andrew G Sokolow et al. Pediatrics. .

Erratum in

Abstract

Background and objectives: Asthma is considered a precaution for use of quadrivalent live attenuated influenza vaccine (LAIV4) in persons aged ≥5 years because of concerns for wheezing events. We evaluated the safety of LAIV4 in children with asthma, comparing the proportion of children with asthma exacerbations after LAIV4 or quadrivalent inactivated influenza vaccine (IIV4).

Methods: We enrolled 151 children with asthma, aged 5 to 17 years, during 2 influenza seasons. Participants were randomly assigned 1:1 to receive IIV4 or LAIV4 and monitored for asthma symptoms, exacerbations, changes in peak expiratory flow rate (PEFR), and changes in the asthma control test for 42 days after vaccination.

Results: We included 142 participants in the per-protocol analysis. Within 42 days postvaccination, 18 of 142 (13%) experienced an asthma exacerbation: 8 of 74 (11%) in the LAIV4 group versus 10 of 68 (15%) in the IIV4 group (LAIV4-IIV4 = -0.0390 [90% confidence interval -0.1453 to 0.0674]), meeting the bounds for noninferiority. When adjusted for asthma severity, LAIV4 remained noninferior to IIV4. There were no significant differences in the frequency of asthma symptoms, change in PEFR, or childhood asthma control test/asthma control test scores in the 14 days postvaccination between LAIV4 and IIV4 recipients. Vaccine reactogenicity was similar between groups, although sore throat (P = .051) and myalgia (P <.001) were more common in the IIV4 group.

Conclusions: LAIV4 was not associated with increased frequency of asthma exacerbations, an increase in asthma-related symptoms, or a decrease in PEFR compared with IIV4 among children aged 5 to 17 years with asthma.

Trial registration: ClinicalTrials.gov NCT03600428.

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Conflict of interest statement

CONFLICT OF INTEREST DISCLOSURES: The authors report no financial conflicts of interest relevant to this work. Dr. Creech reports receipt of a research grant from Merck Vaccines, personal fees for consultation for Astellas, Horizon Pharma, Altimmune, Janssen, Vir, and Premier Healthcare (unrelated to current work), and royalties from UpToDate (unrelated to current work). Dr. Walter reports serving as principal investigator for Pfizer-funded studies of COVID-19 vaccines, co-investigator for a vaccine study funded by Moderna, and an advisory board member for Vaxcyte (unrelated to current work).

Figures

FIGURE 1
FIGURE 1
CONSORT diagram.
FIGURE 2
FIGURE 2
Asthma-related symptoms, by participant and parental report, in the 14 days after immunization, with corresponding error bars.
See this image and copyright information in PMC

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