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Proposal 1000

Title of the Proposed Research

Review of fever and febrile convulsion rates in children after trivalent influenza vaccine.

Lead Researcher

Dr Jean Li-Kim-Moy, MBBS, FRACP

Affiliation

National Centre for Immunisation Research and Surveillance
The Children’s Hospital at Westmead
Sydney, AU

Funding Source

Department of Health and Ageing, Australia

Potential Conflicts of Interest

Lead Researcher: None

Researcher 1: Robert Booy has received funding from CSL, Roche, Sanofi, GlaxoSmithKline (GSK) and Wyeth to attend and present at scientific meetings; any funding received is directed to a research account at The Children’s Hospital at Westmead

Researcher 2: None

Management of Real or Potential Conflicts of Interest
Full and complete disclosure of interests when the research is presented and published.

Data Sharing Agreement Date

8 September 2014

Lay Summary

Influenza is a common respiratory infection which particularly troubles the elderly and children, in whom there is a significant health burden. Each winter, large numbers of children are assessed in emergency departments or admitted to hospital. Whilst influenza is usually mild and self resolving, it rarely can cause serious or life threatening illness. Increasingly more countries, including the United States, are recommending universal influenza vaccination of children.

There is very little published data summarising safety aspects of trivalent influenza vaccines in children, such as fever. This was brought to light due to an unexpected observed increase in fever and febrile convulsions in influenza-vaccinated children during the 2010 Australian influenza season. This was subsequently attributed to bioCSL’s Fluvax and Fluvax Junior products. Public confidence in influenza vaccination and vaccination rates in children have dropped as a result.

There is a need to gain further understanding of influenza vaccine safety in the paediatric population. In a systematic review we have conducted, we have investigated fever, febrile convulsion rates, and serious adverse events (SAEs) using published and unpublished randomised controlled clinical trials and observational studies. This has highlighted the major difficulties of comparing published data due to each study’s variable methods (such as definitions of fever, age ranges of participants, and length of monitoring), and the limited summaries of results available in published reports.

To further clarify the situation, our aim is to obtain individual-level data from clinical trials of paediatric influenza vaccines to allow much more effective comparison between studies. We hope to be able to summarise, on a descriptive level, information about fever including its frequency and severity, when it occurs after vaccination, and what effect, if any, do preventative or treatment doses of fever medication such as paracetamol or ibuprofen have on these rates.

Individual level data will allow these results to be analysed and pooled as appropriate and descriptively reported. It is hoped to incorporate the individual level data from GSK and other companies’ influenza studies into a systematic review on the topic.

Study Data Provided

Study 111751: Immunogenicity and safety of GSK Biologicals’ thimerosal-free TIV flu vaccine versus a licensed comparator in children
Study 113275: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children
Study 104858: A phase III, single-blind, randomized study to evaluate the immunogenicity and safety of Fluarix® (GSK Biologicals) compared with Fluzone® (Aventis Pasteur/Sanofi) administered intramuscularly in children (6 months and older)
Study 114541: Efficacy study of GSK Biologicals’ quadrivalent influenza vaccine, GSK2282512A, (FLU Q-QIV) when administered in children
Study 113314: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children
Study 112999: Immunogenicity & safety study of GSK Biologicals’ thimerosal-free trivalent influenza vaccine (TIV) versus a licensed comparator in children

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation