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36 months: A comparison of published and unpublished studies

Kaczmarek M.C., Duong U.T., Ware R.S., Lambert S.B. and Kelly H.A. (2013) 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36 months: A comparison of published and unpublished studies. Vaccine, 31 46: 5359-5365. doi:10.1016/j.vaccine.2013.09.005


Author Kaczmarek M.C.
Duong U.T.
Ware R.S.
Lambert S.B.
Kelly H.A.
Title 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36 months: A comparison of published and unpublished studies
Journal name Vaccine   Check publisher's open access policy
ISSN 0264-410X
1873-2518
Publication date 2013-11-04
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1016/j.vaccine.2013.09.005
Volume 31
Issue 46
Start page 5359
End page 5365
Total pages 7
Place of publication London, England, U.K.
Publisher Elsevier Ltd
Collection year 2014
Language eng
Subject 2400 Immunology and Microbiology
2725 Infectious Diseases
2739 Public Health, Environmental and Occupational Health
3400 Veterinary
1313 Molecular Medicine
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months, searching PubMED and Google Scholar for English language articles from 2000 onwards, and initiated or ongoing unpublished studies since September 2007 using clinicaltrials.gov.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and collated results using a standard data extraction template.We identified a total of 909 published papers and unpublished trials from a search conducted on 23 January 2013, 669 from Google Scholar, 114 from PubMed and 126 from the Clinicaltrials.gov online database. After excluding 890 published papers or unpublished trials, 5 published papers and 14 unpublished trials were included in this review.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.
Keyword Adverse effects
Febrile
Fever
Influenza vaccines
Review
Seizures
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2014 Collection
Queensland Children's Medical Research Institute Publications
School of Public Health Publications
 
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