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Review of post-vaccination fever and antipyretic use and their relation to vaccine immunogenicity after quadrivalent influenza vaccine in children.








Review of post-vaccination fever and antipyretic use and their relation to vaccine immunogenicity after quadrivalent influenza vaccine in children.


Dr Jean Li-Kim-Moy


National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead






16 August 2018


Influenza is a common respiratory infection which particularly troubles the elderly and children, in whom there is a significant health burden. Each winter, large numbers of children are assessed in emergency departments or admitted to hospital. Whilst influenza is usually mild and self-resolving, it rarely can cause serious or life-threatening illness. Increasingly more countries, for example the United States, Canada and the United Kingdom, are moving towards or have instituted universal influenza vaccination of children.Through our previous research proposal (1000) we investigated fever and antipyretic use after trivalent influenza vaccine in children. We found that there were significant associations between those children who experienced fever after vaccination, and higher vaccine immunogenicity. Conversely, we found that antipyretic use in the post-vaccination period appeared to decrease the immune response to the influenza vaccine, independently of whether there was fever present. This study is currently in press (The Pediatric Infectious Diseases Journal DOI: 10.1097/INF.0000000000001949).These findings could have relevance given that influenza vaccine is only moderately effective at preventing infection and there have been concerns that this effectiveness may be lower in young children. Therefore, in these individuals, relatively small changes in vaccine immunogenicity can have an important impact on the vaccine effectiveness. We need to investigate further to see if the effects we found occur more widely in other influenza clinical trials, particularly those involving the current generation of quadrivalent influenza vaccines which contain 4 influenza strains rather than 3. Our aim is to obtain individual-level data from GSK's clinical trials of paediatric quadrivalent influenza vaccines to document rates of fever and antipyretic use, when in the post-vaccination period they are used, and to investigate their effects on vaccine immunogenicity both within studies and by pooling vaccine recipients across studies.



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Statistical Analysis Plan