Bexsero (meningococcal group B vaccine) meets endpoints in phase III study for meningococcal disease- GlaxoSmithKline

GlaxoSmithKline has presented new data for its meningococcal group B vaccine, Bexsero (meningococcal group B vaccine) comparing safety and immunogenicity with different dosing schedules in infants and young children, at the annual meeting of the European Society for Paediatric Infectious Diseases (ESPID). The phase IIIb study (V72_28) met its primary and secondary endpoints, showing comparable immune response and safety in infants receiving a reduced schedule of two primary doses of Bexsero plus a booster dose compared to those receiving the current EU approved schedule of three primary doses of Bexsero plus a booster dose.

Across the different groups, the majority of infants and children had a high immune response irrespective of the dosing schedule, with similar safety profiles seen across the groups. Safety and tolerability data from this study are consistent with data from previous studies. In addition, concomitant administration of Menjugate (Meningococcal Group C Conjugate Vaccine) with Bexsero in infants was shown to be non-inferior to Menjugate alone, with similar safety profiles. The full results for this study will be submitted for publication in a peer-reviewed journal.

Comment: In September 2015, the UK became the first country in the world to implement a routine immunisation programme with Bexsero with a reduced dosing schedule (2+1 series given at 2, 4 and 12 months).