Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: A phase III, randomized, multicentre, lot-to-lot consistency study
Kirsten P Perrett, Jodie McVernon, Peter C Richmond, Helen Marshall, Michael Nissen, Allison August, Sandra Percell, Daniela Toneatto, Terry Nolan
VACCINE | ELSEVIER SCI LTD | Published : 2015
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 hum..View full abstract
Awarded by Australian National Health and Medical Research Council
This study was funded by Novartis Vaccines. Dr. Perrett, and A/Professors McVernon and Marshall (1016272) are recipients of Research Fellowships from the Australian National Health and Medical Research Council.