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  • The risk of fever following one dose of trivalent inactivated influenza vaccine in children aged ≥6 months to <36 months: A comparison of published and unpublished studies

    Author(s)
    Kaczmarek, Marlena C
    Duong, Uyen T
    Ware, Robert S
    Lambert, Stephen B
    Kelly, Heath A
    Griffith University Author(s)
    Ware, Robert
    Year published
    2013
    Metadata
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    Abstract
    There are limited summary data published on the risk of fever and febrile seizures in children following influenza vaccination. We performed a review of the risk of fever and febrile seizures following receipt of trivalent inactivated influenza vaccine (TIV) in children aged ≥6 months to <36 months, searching PubMED and Google Scholar for English language articles from 2000 onwards, and initiated or ongoing unpublished studies since September 2007 using clinicaltrials.gov. Exclusions included other vaccine co-administration, missing ages or participant numbers, or unmeasured fever. We reviewed articles and collated results ...
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    There are limited summary data published on the risk of fever and febrile seizures in children following influenza vaccination. We performed a review of the risk of fever and febrile seizures following receipt of trivalent inactivated influenza vaccine (TIV) in children aged ≥6 months to <36 months, searching PubMED and Google Scholar for English language articles from 2000 onwards, and initiated or ongoing unpublished studies since September 2007 using clinicaltrials.gov. Exclusions included other vaccine co-administration, missing ages or participant numbers, or unmeasured fever. We reviewed articles and collated results using a standard data extraction template. We identified a total of 909 published papers and unpublished trials from a search conducted on 23 January 2013, 669 from Google Scholar, 114 from PubMed and 126 from the Clinicaltrials.gov online database. After excluding 890 published papers or unpublished trials, 5 published papers and 14 unpublished trials were included in this review. Extracted data on number of events, children at risk and time of follow-up were converted to the risk of fever, which was averaged per week of follow-up (referred to as ‘averaged weekly risk’). Following one dose of TIV, the median averaged weekly risk of any fever (≥37.5 °C) was 26.0% (range 10.3–70.0%) in unpublished trials compared to 8.2% (range 5.3–28.3%) in published papers (p = 0.04). The median averaged weekly risk of severe fever (≥39.0 °C) was 3.2% (range 0–10.0%) and 2.0% (range 0.6–17.0%), respectively (p = 0.91). Variation in the reporting of fever by participant age groups, time since vaccination and the definition or measurement of fever resulted in a wide range of risk estimates. Reporting of febrile reactions should be standardised to allow comparison between manufacturers and influenza seasons.
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    Journal Title
    Vaccine
    Volume
    31
    Issue
    46
    DOI
    https://doi.org/10.1016/j.vaccine.2013.09.005
    Subject
    Biological sciences
    Microbiology not elsewhere classified
    Agricultural, veterinary and food sciences
    Biomedical and clinical sciences
    Publication URI
    http://hdl.handle.net/10072/172364
    Collection
    • Journal articles

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