Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia

Abstract

BACKGROUND: Four-component meningococcal B (4CMenB) vaccine is licensed in many countries but has had limited use in adolescents despite this age group being at increased risk of meningococcal disease. OBJECTIVES: To assess the safety profile of two doses of 4CMenB in adolescents. METHODS: Cluster randomised controlled trial of senior school students in South Australia (SA) with participating schools randomised to intervention (4CMenB) or control. Vaccine safety was monitored using the South Australian Vaccine Safety Surveillance System (SAVSS), a spontaneous reporting system for adverse events following immunisation (AEFI) with enhanced follow-up of AEFI. RESULTS: 58,637 doses of 4CMenB vac..