1. Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma
- Author
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Paul J. Turner, Louise Fleming, Sejal Saglani, Jo Southern, Nick J. Andrews, Elizabeth Miller, Alexandra Adams, Christine Doyle, Michel Erlewyn-Lajeunesse, Katy Fidler, Atul Gupta, Stephen M. Hughes, Andrew Ives, Nicola Jay, Sonal Kansra, Louise Michaelis, Samantha Moss, Clare Murray, Prasad Nagakumar, Graham Roberts, Paul Seddon, Ian Sinha, Gary Stiefel, Huw M. Thomas, Medical Research Council (MRC), and Department of Health
- Subjects
0301 basic medicine ,Male ,Pediatrics ,LAIV, Live attenuated influenza vaccine ,Exacerbation ,Allergy ,ADVISORY-COMMITTEE ,INTRANASAL ,RECOMMENDATIONS ,ACQ, Asthma Control Questionnaire ,0302 clinical medicine ,Immunology and Allergy ,Live attenuated influenza vaccine ,030212 general & internal medicine ,Prospective Studies ,Child ,(c)ACT, (Children’s) Asthma Control Test ,ICS, Inhaled corticosteroid ,SNIFFLE-4 Study Investigators ,Vaccination ,Orthomyxoviridae ,Respiratory Function Tests ,ACT, Asthma Control Test ,1107 Immunology ,Influenza Vaccines ,Child, Preschool ,Disease Progression ,Female ,influenza ,Life Sciences & Biomedicine ,AE, Adverse event ,Moderate to severe ,medicine.medical_specialty ,YOUNG-CHILDREN ,Adolescent ,Immunology ,Inhaled corticosteroids ,POSTMARKETING EVALUATION ,live attenuated influenza vaccine ,FREQUENCY ,Vaccines, Attenuated ,immunization ,Article ,03 medical and health sciences ,McNemar's test ,children ,Influenza, Human ,medicine ,Humans ,TRACK, Test for Respiratory and Asthma Control for Kids ,Asthma ,Respiratory Sounds ,Science & Technology ,business.industry ,medicine.disease ,EFFICACY ,PREVENTION ,United Kingdom ,respiratory tract diseases ,EXACERBATIONS ,030104 developmental biology ,Immunization ,business ,IIV, Injected influenza vaccine ,Follow-Up Studies - Abstract
Background:Live attenuated influenza vaccine (LAIV) is recommended for annual influenza vaccination in children from age 2 years. However, some guidelines recommend against its use in children with asthma or recurrent wheeze due to concerns over its potential to induce wheezing. Objective: To assess the safety of LAIV in children with moderate-severe asthma, and in preschool children with recurrent wheeze. Methods: Prospective, multi-center, open label, phase IV intervention studyin 14 specialist UK clinics.LAIV was administered under medical supervision, with follow-up of asthma symptoms 72 hours and 4 weeks late, using validated questionnaires.Clinical Trials.gov registration NCT02866942, EU Clinical Trials registration 2016-002352-24. Results: 478 young people (median 9.3, range 2–18 years) with physician-diagnosed asthma or recurrent wheeze were recruited, including 208 (44%) prescribed high-dose inhaled corticosteroids and 122 (31%) with severe asthma.There was no significant change in asthma symptoms in the 4 weeks following administration (median change 0, P=.26, McNemar’s test), with no impact of level of baseline asthma control/symptoms in predicting either a worsening of asthma or exacerbation following LAIV using a regression model. 47 subjects (14.7%, 95%CI 11% to 19.1%) reported a severe asthma exacerbation in the four weeks following immunization, requiring short course of systemic corticosteroids; in four cases, this occurred within 72 hours of vaccine. No association with asthma severity, baseline lung function or asthma control was identified.Conclusions: LAIV appears to be well-tolerated in the vast majority of children with asthma or recurrent wheeze, includingthosewhose asthma is categorized as severe or poorly controlled
- Published
- 2019