Review of the Clinical Studies Used for Marketing Approval of the Vaccine Bexsero®

This dataset includes all the clinical studies used for the evaluation of the marketing approval of the vaccine Bexsero® (also known under the names of 4CMenB and rMenB + OMV NZ) filed by Novartis with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or Health Canada.<br>A total of 23 clinical studies were used in these assessments and 5 studies were required by the FDA as post-marketing monitoring. The cited clinical studies totalled about 18,367 research participants who received either the Final Vaccine Formulation (rMenB + OMV NZ), an Early Vaccine Formulation (rMenB) or other comparators.