BACKGROUND: For decades, a broadly effective vaccine against serogroup B 
Neisseria meningitidis (MenB) has remained elusive. Recently, a four-component 
recombinant vaccine (4CMenB) has been developed and is now approved in Europe, 
Canada, Australia and some Latin American countries. This phase III, randomized 
study evaluated the lot consistency, early immune responses and the safety 
profile of 4CMenB in 11 to 17-year-old adolescents in Australia and Canada 
(NCT01423084).
METHODS: In total, 344 adolescents received two doses of one of 2 lots of 
4CMenB, 1-month apart. Immunogenicity was assessed before, 2-weeks and 1-month 
following the second vaccination. Serum bactericidal activity using human 
complement (hSBA) was measured against three reference strains 44/76-SL, 5/99 
and NZ98/254, selected to express one of the vaccine antigens; Neisseria adhesin 
A (NadA), factor H binding protein (fHbp) and porin A (PorA) containing outer 
membrane vesicle (OMV), respectively. Responses to the Neisseria heparin binding 
antigen (NHBA) were assessed with enzyme linked immunosorbent assay (ELISA). 
Local and systemic reactions were recorded for 7 days following each 
vaccination; unsolicited adverse events were monitored throughout the study.
RESULTS: Immunological equivalence of the two lots of 4CMenB was established at 
1-month. At baseline, ≤7% of participants had hSBA titers ≥5 to all three 
reference strains. Two weeks following the second dose of 4CMenB, all 
participants had hSBA titers ≥5 against fHbp and NadA compared with 84-96% 
against the PorA reference strains. At 1-month, corresponding proportions were 
99%, 100% and 70-79%, respectively. Both lots were generally well tolerated and 
had similar adverse event profiles.
CONCLUSIONS: Two doses of 4CMenB had an acceptable safety profile and induced a 
robust immune response in adolescents. Peak antibody responses were observed at 
14 days following vaccination. While a substantial non-uniform antigen-dependent 
early decline in antibody titers was seen thereafter, a significant percentage 
of participants continued to maintain protective hSBA titers at 1-month.