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Nasal spray flu vaccine safety study and how to generate data quickly

McNaughton, Lynn et al.

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

Drug Safety 39, 323–333 (2016)

Published: 21 January 2016



A pilot non-interventional cohort post-authorisation safety study was conducted during the 2014/2015 influenza season in England by a team of scientists from the Drug Safety Research Unit.

Their primary objective was to estimate the crude incidence rate of adverse events of interest (AEIs) following vaccination with the nasal QLAIV (Fluenz Tetra) early in the 2014/2015 influenza season in children and adolescents in England.


In total, 23 general practitioner (GP) practices, 17 primary schools and six high schools across England took part in the study. 385 participants were selected with an age range of 2–17 years. Participant outcomes were captured through questionnaires (surface mail, telephone, e-questionnaire).


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Adverse events of interest (AEIs)

The most frequently reported AEIs were


nasal congestion - 167

malaise (feeling unwell) - 87

cough - 80


Nausea, vomiting, and headache were also reported. Crude incidence rates of generally feeling unwell (malaise), mouth and throat pain and wheezing increased with age. AEIs for which the rate consistently decreased with age included high temperature and cough.


KEY POINTS

  • "The study focused on the detection of common AEIs that manifest in the short-term post-vaccination, which is indicative of increased reactogenicity, as laid out in the interim guidance, rather than uncommon reactions. Other study designs may be more appropriate for the detection of rare adverse events. For example, case-control studies have been used to identify uncommon adverse events such as Bell’s palsy following vaccination with inactivated influenza vaccines."


  • "Response rates ranged from 66 to 86 % in this study, resulting in the potential for non-response bias. However, the response rate in this study is higher than the reporting rates of suspected adverse drug reactions in the Yellow Card Scheme."


  • "This study has shown that data can be generated quickly by gathering vaccinee- or participant-level feedback following vaccination using both an online survey and through the use of a well-completed simple paper questionnaire."


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