tetano
Editor, Senior Moderator
Vaccine. 2013 Sep 18. pii: S0264-410X(13)01232-2. doi: 10.1016/j.vaccine.2013.09.005. [Epub ahead of print]
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36 months: A comparison of published and unpublished studies.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 MC, Duong UT, Ware RS, Lambert SB, Kelly HA.
Source
Queensland Children's Medical Research Institute, The University of Queensland, and Children's Health Service, Queensland Health, Brisbane, Queensland, Australia; School of Population Health, The University of Queensland, Brisbane, Queensland, Australia; Epidemiology Unit, Victorian Infectious Diseases Reference Laboratory, Melbourne, Victoria, Australia. Electronic address: Marlena.kaczmarek@mh.org.au.
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months, searching PubMED and Google Scholar for English language articles from 2000 onwards, and initiated or ongoing unpublished studies since September 2007 using clinicaltrials.gov.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 We identified a total of 909 published papers and unpublished trials from a search conducted on 23 January 2013, 669 from Google Scholar, 114 from PubMed and 126 from the Clinicaltrials.gov online database. After excluding 890 published papers or unpublished trials, 5 published papers and 14 unpublished trials were included in this review.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 Following one dose of TIV, the median averaged weekly risk of any fever (≥37.5?C) was 26.0% (range 10.3-70.0%) in unpublished trials compared to 8.2% (range 5.3-28.3%) in published papers (p=0.04).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.
Copyright ? 2013. Published by Elsevier Ltd.
KEYWORDS:
Adverse effects, Febrile, Fever, Influenza vaccines, Review, Seizures
PMID:
24055353
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24055353
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 MC, Duong UT, Ware RS, Lambert SB, Kelly HA.
Source
Queensland Children's Medical Research Institute, The University of Queensland, and Children's Health Service, Queensland Health, Brisbane, Queensland, Australia; School of Population Health, The University of Queensland, Brisbane, Queensland, Australia; Epidemiology Unit, Victorian Infectious Diseases Reference Laboratory, Melbourne, Victoria, Australia. Electronic address: Marlena.kaczmarek@mh.org.au.
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.
Copyright ? 2013. Published by Elsevier Ltd.
KEYWORDS:
Adverse effects, Febrile, Fever, Influenza vaccines, Review, Seizures
PMID:
24055353
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24055353