Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

J Li-Kim-Moy; J K Yin; H Rashid; G Khandaker; C King; N Wood; K K Macartney; C Jones; R Booy

doi:10.2807/1560-7917.ES2015.20.24.21159

Review articles Open Access

Like 0

Download

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children
J Li-Kim-Moy^1,2 , J K Yin^1,2 , H Rashid¹ , G Khandaker^1,2,3 , C King^1,2 , N Wood^1,2 , K K Macartney^1,2,4 , C Jones^2,3,4,5 , R Booy^1,2,4,5
View Affiliations Hide Affiliations

Affiliations: ¹ National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, New South Wales, Australia ² Sydney Medical School, The University of Sydney, New South Wales, Australia ³ Centre for Perinatal Infection Research, The Children’s Hospital at Westmead, New South Wales, Australia ⁴ Department of Microbiology and Infectious Diseases, The Children’s Hospital at Westmead, New South Wales, Australia ⁵ Marie Bashir Institute for Infectious Diseases and Biosecurity, University of Sydney, New South Wales, Australia

Correspondence:
J Li-Kim-Moy
jean.likimmoy health.nsw.gov.au

Correspondence: J Li-Kim-Moy
jean.likimmoy health.nsw.gov.au
View Citation Hide Citation

Citation style for this article: Li-Kim-Moy J, Yin J K, Rashid H, Khandaker G, King C, Wood N, Macartney K K, Jones C, Booy R. Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children. Euro Surveill. 2015;20(24):pii=21159. https://doi.org/10.2807/1560-7917.ES2015.20.24.21159 Received: 22 May 2014

Abstract

In 2010, increased febrile convulsions (FC) occurred after administration of inactivated trivalent influenza vaccine (TIV) in Australia. We systematically reviewed the rates of fever, FC and serious adverse events (SAEs) after TIV, focussing on published and unpublished clinical trial data from 2005 to 2012, and performed meta-analysis of fever rates. From 4,372 records in electronic databases, 18 randomised controlled trials (RCTs), 14 non-randomised clinical trials, six observational studies and 12 registered trials (five RCTs and seven non-randomised) were identified. In published RCTs, fever?≥?38?°C rates after first dose of non-adjuvanted TIV were 6.7% and 6.9% for children aged 6-35 months and?≥?3 years, respectively. Analysis of RCTs by vaccine manufacturer showed pooled fever estimates up to 5.1% with Sanofi or GlaxoSmithKline vaccines; bioCSL vaccines were used in two non-randomised clinical trials and one unpublished RCT and were associated with fever in 22.5-37.1% for children aged 6-35 months. In RCTs, FCs occurred at a rate of 1.1 per 1,000 vaccinated children. While most TIVs induced acceptably low fever rates, bioCSL influenza vaccines were associated with much higher rates of fever in young children. Future standardised study methodology and access to individual level data would be illuminating. .