Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Rhian McNaughtonS A W Shakir

Abstract

Fluenz Tetra is an intranasal quadrivalent live attenuated influenza vaccine (QLAIV) and is recommended as the vaccine of choice for children in the 2014/2015 influenza season vaccination programme in the UK. The primary objective of the study was to estimate the crude incidence rate of adverse events of interest (AEIs) following vaccination with the nasal QLAIV early in the 2014/2015 influenza season in children and adolescents in England. A pilot non-interventional cohort post-authorisation safety study (PASS) was conducted during the 2014/2015 influenza season in England. Vaccinees were recruited via the mass vaccination programme in England. Participant outcomes, validated by a healthcare professional (general practitioner) where appropriate, were captured through questionnaires (surface mail, telephone, e-questionnaire). Data analysis comprised descriptive statistics and calculation of event risks and incidence rates, stratified by age group and selected co-morbidities. The final evaluable cohort consisted of 385 participants; the median (interquartile range) age was 4 (3-9) years with a range of 2-17 years, and 53.2 % were female. The most frequently reported AEI was nasal congestion (n = 167; 43.4 %; 312.3 per 1000 patie...Continue Reading

References

Feb 27, 2004·The New England Journal of Medicine·Margot MutschRobert Steffen
Dec 14, 2006·The Journal of Infectious Diseases·Anthony S Fauci
Apr 28, 2009·The Pediatric Infectious Disease Journal·Humberto Bracco NetoUNKNOWN D153-P504 LAIV Study Group

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Citations

Aug 27, 2016·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·Simon de LusignanRichard Pebody
Feb 2, 2017·Therapeutic Delivery·Nirmal MarasiniIstvan Toth
Jan 4, 2018·Human Vaccines & Immunotherapeutics·Claudia Maria TrombettaEmanuele Montomoli
Aug 6, 2019·Frontiers in Medicine·Carla TorreAna Paula Martins
Oct 23, 2020·BMJ Evidence-based Medicine·Sandeep DhandaSaad Shakir

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