WHO/Health Canada meeting on regulatory considerations for evaluation and licensing of new meningococcal Group B vaccines, Ottawa, Canada, 3-4 October 2011

► Measurement of hSBA levels is appropriate for evaluation of multicomponent protein-based MenB vaccines. ► Approaches towards standardization of assays were discussed. ► Post-marketing surveillance is essential to estimate vaccine effectiveness and breadth of coverage. ► More reliable assays to control pyrogenicity should be developed and validated.