Immunogenicity and Tolerability of Recombinant Serogroup B Meningococcal Vaccine Administered With or Without Routine Infant Vaccinations According to Different Immunization Schedules

Reduction inNeisseria meningitidisinfection in Italy after Meningococcal C conjugate vaccine introduction: A time trend analysis of 1994–2012 series

“…This information would enable better assessment of changes in the distribution of serogroups and the impact of vaccination campaigns, especially now that a vaccine against serogroup B is available. 37 …”

Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents

“…[19][20][21][22] Results from Phase 2 and 3 clinical studies demonstrated that 4CMenB elicited strong bactericidal responses against the vaccine antigens and was generally well tolerated when used in infants and children, adolescents and adults. [21][22][23][24][25][26] 4CMenB has been approved in the EU, Australia, Canada, Chile, and Uruguay for use in individuals beginning from 2 months of age and in the US for use in individuals 10 to 25 y of age.…”

A phase II randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II)

“…However, inclusion of 4CMenB in routine infant vaccination schedules, with concomitant administration with DTaP-HBV-IPV/Hib and pneumococcal conjugate vaccines, was associated with an incremental increase in reactogenicity, particularly fever and injection site tenderness. [4][5][6] As increased fever could compromise the acceptability of 4CMenB in infant vaccination schedules, we performed a study to investigate formulations with reduced OMV content to inform future vaccine development, as well as the use of prophylactic paracetamol as reported in the companion paper. 11 As previously reported, 3,4 the rMenB vaccine formulation containing only recombinant proteins without OMV displayed slightly lower rates of local and systemic reactogenicity, including fever, and were consistent with the rates reported for MenC vaccination in that part of the study reported in the complementary paper.…”

“…Geometric mean concentrations (GMcs) (95% cI) of eLIsa antibodies (eL.U/mL) against the NhBa component Table 1). [4][5][6] The prelicensure formulation had the same composition prepared from pre-licensure materials and the experimental formulations contained the same components in the variable combinations and quantities described in Table 1. Concomitantly administered routine infant vaccines were DTaP-HBV-IPV/Hib and 7-valent pneumococcal conjugate vaccine (PCV7, Prevenar ® ; Wyeth, Philadelphia, USA).…”

“…1,2 This has led to the use of novel technologies to develop vaccines to meet this unmet medical need, which has recently resulted in the approval of a multicomponent, recombinant protein serogroup B vaccine, 4CMenB (Bexsero ® ) in Europe and Australia. [3][4][5][6] Prior to 4CMenB, the response to meningococcal serogroup B disease outbreaks was to develop vaccines based on outer membrane vesicles (OMV) of the clonal strains responsible for…”