ArticleBMJ open2011
Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine.
Article in BMJ open, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.
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Who cites it
37 citing papers in PubMed, 125 citations in OpenAlex.
- Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa.Human vaccines & immunotherapeutics · 2019Trial
- Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults.BMC infectious diseases · 2018Trial
- Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents.Influenza and other respiratory viruses · 2013Trial
- Safety and immunogenicity of 2010–2011 A/H1N1pdm09-containing trivalent inactivated influenza vaccine in adults previously given AS03-adjuvanted H1N1 2009 pandemic vaccine: results of a randomized trial.Human vaccines & immunotherapeutics · 2013Trial
- Statistical Methods for Multi-jurisdictional Australian Vaccine Safety Investigations of Rare Adverse Events.Drug safety · 2026Article
- Genetic Optimization of Early 2009 Pandemic H1N1 Vaccine Strains for Improved Replication in Embryonated Chicken Eggs.Journal of microbiology and biotechnology · 2025Article
- A High-Yield Recombinant Inactivated Whole-Virion Nasal Influenza A(H1N1)pdm09 Virus Vaccine with an Attenuated PB2 Gene.International journal of molecular sciences · 2025Article
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- Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation study.NPJ vaccines · 2024Article
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- Information systems for vaccine safety surveillance.Human vaccines & immunotherapeutics · 2022Review
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- Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review.Frontiers in immunology · 2021Review
- Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.BMJ open · 2020Article
- Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia.PloS one · 2019Article
- Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives.Human vaccines & immunotherapeutics · 2019Review
- Observational
- Risk of seizures after immunization in children with epilepsy: a risk interval analysis.BMC pediatrics · 2018Article
- Evaluation of Combination Measles-Mumps-Rubella-Varicella Vaccine Introduction in Australia.JAMA pediatrics · 2017Article
- Insights From Flutracking: Thirteen Tips to Growing a Web-Based Participatory Surveillance System.JMIR public health and surveillance · 2017Article
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 2010 influenza vaccination program for children aged 6 months to 4 years in Western Australia (WA) was suspended following reports of severe febrile reactions, including febrile convulsions, following vaccination with trivalent inactivated influenza vaccine (TIV).
methodsTo investigate the association between severe febrile reactions and TIV, three studies were conducted: (i) rates of febrile convulsions within 72 h of receiving TIV in 2010 were estimated by vaccine formulation and batch; (ii) numbers of children presenting to hospital emergency departments with febrile convulsions from 2008 to 2010 were compared; and (iii) a retrospective cohort study of 360 children was conducted to compare the reactogenicity of available TIV formulations.
findingsIn 2010, an estimated maximum of 18,816 doses of TIV were administered and 63 febrile convulsions were recorded, giving an estimated rate of 3.3 (95% CI 2.6 to 4.2) per 1000 doses of TIV administered. The odds of a TIV-associated febrile convulsion was highly elevated in 2010 (p<0.001) and was associated with the vaccine formulations of one manufacturer-Fluvax and Fluvax Junior (CSL Biotherapies). The risk of both febrile convulsions (p<0.0001) and other febrile reactions (p<0.0001) was significantly greater for Fluvax formulations compared to the major alternate brand. The risk of febrile events was not associated with prior receipt of TIV or monovalent 2009 H1N1 pandemic vaccine. The biological cause of the febrile reactions is currently unknown.
interpretationOne brand of influenza vaccine was responsible for the increase in febrile reactions, including febrile convulsions. Until the biological reason for this is determined and remediation undertaken, childhood influenza vaccination programs should not include Fluvax-type formulations and enhanced surveillance for febrile reactions in children receiving TIV should be undertaken.
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Registered trials
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