CANVAS: Rapid monitoring of adverse events following vaccination with meningococcal serogroup B vaccine

In December 2013, the multicomponent Meningococcal Serogroup B (4CMenB) vaccine (Bexsero®) was approved for use in children 2 months-17 years of age in Canada.  The vaccine has been used to control outbreaks of meningitis on university campuses in the United States and in regions of Québec. The influenza safety surveillance methodology was adapted to monitor vaccine safety during the Quebec meningitis vaccination campaign.

To further enhance vaccine safety monitoring for new vaccines, we will develop a model readiness plan for surveillance of adverse events following vaccination with a meningitis B vaccine.  It will include developing a template protocol, informed consent, communication and recruitment strategies, safety survey tool, data management and analysis plan and budget.  We will incorporate lessons learned from the use of the vaccine in Quebec to develop a plan that can be rapidly implemented in an emergency situation.

Team Members: