LA-SER Research Case Study: Case Control Surveillance

A Prospective Case Control Surveillance Study to Survey the Mass-Vaccination Against A/H1N1 virus

>         Case background

  • The EMA Requested that Guillain-Barre Syndrome be surveyed.

>         Approach

  • PGRx Network of autoimmune disorder used by several manufacturers in their risk management plans
  • 145 Incident GBS Cases with 1,080 Controls
  • 1 Country (France)
  • 42 Neurology Centres 457 GPs

>         Results

  • The Study confirmed that Influenza like syndromes is a likely risk factor for Guillain-Barre Syndrome.

  • Conversely, no new concerns arose relating to influenza vaccination.
  • The PGRx process allowed for a very rapid completion of the study.