A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults☆

•Largest controlled safety study of a recombinant meningococcal serogroup B vaccine.•SAEs occurred in lower percentage of bivalent rLP2086 group than control group.•SAEs related to vaccine were rare.•Rates of medically-attended AEs were similar between vaccine groups.•Bivalent rLP2086 was safe and tolerable in adolescents and young adults 10–25 years.