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of trivalent inactivated influenza vaccine in children aged ≥6 months to &lt;36 months: A comparison of published and unpublished studies

Kaczmarek, Marlena; Duong, Uyen T.; Ware, Robert S.; Lambert, Stephen B.; Kelly, Heath

doi:10.1016/j.vaccine.2013.09.005

Cited by 10 publications

(7 citation statements)

References 21 publications

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“…A recent systematic review of fever by Kaczmarek et al following dose 1 of inactivated TIV, reported a similar rate (8.0%) for any fever in children aged six to < 36 months after non-adjuvanted TIV, using weighted average weekly risk [66]. However, our study, by using a proportion meta-analysis method, allowed inclusion of a broader range of studies.…”

Section: Discussionsupporting

confidence: 48%

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

et al. 2015

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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systematically reviewed the rates of fever, FC and serious adverse events (SAEs) after TIV, focussing on published and unpublished clinical trial data from 2005 to 2012, and performed meta-analysis of fever rates.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5.1% with Sanofi or GlaxoSmithKline vaccines; bioCSL vaccines were used in two non-randomised clinical trials and one unpublished RCT and were associated with fever in 22.5-37.1% for children aged 6-35 months.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.

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Section: Discussionsupporting

confidence: 48%

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

et al. 2015

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“…We found TIV to be well tolerated by young children with adverse events experienced being predominantly mild or moderate in severity. Rates of fever after TIV were consistent with recent observational studies and systematic reviews of fever after inactivated influenza vaccination . No febrile seizures or SAEs were reported.…”

Section: Discussionsupporting

confidence: 86%

Influenza vaccine efficacy in young children attending childcare: A randomised controlled trial

Li‐Kim‐Moy

Yin

Heron

et al. 2016

J Paediatrics Child Health

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“…The number of study participants was determined from power calculations using estimates of the expected percentage of fever in vaccinees (5%–10%) 16 , 17 . A sample size of 865 was calculated to achieve the point estimate with 95% confidence intervals of 2%–5% absolute precision.…”

Section: Methodsmentioning

confidence: 99%

The safety of seasonal influenza vaccines in Australian children in 2013

Wood

Blyth²,

Willis³

et al. 2014

Medical Journal of Australia

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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

Cited by 10 publications

References 21 publications

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

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

Influenza vaccine efficacy in young children attending childcare: A randomised controlled trial

The safety of seasonal influenza vaccines in Australian children in 2013

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