Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined(Sanofi)

Menveo is a quadrivalent meningococcal polysaccharide conjugate vaccine containing the four Neisseria meningitidis capsular polysaccharides, A, C, W135, and Y, each conjugated to the mutant diphtheria toxin, known as crossreactive material 197 (CRM(197)). Administration of a single dose of the Menveo vaccine elicited a strong immune response against all four vaccine serogroups in adolescents and adults in randomized, single- or multicenter, phase II or III trials. In adolescents, Menveo was generally more immunogenic against vaccine serogroups than the polysaccharide conjugate vaccine Menactra or the unconjugated polysaccharide vaccine Menomune, in terms of seroresponse and/or seroprotection rates and geometric mean titers (GMTs) 1 month post-vaccination in two phase II or III studies. In two phase III trials in adults aged 19-55 years, the immunogenicity of Menveo was generally noninferior or superior to that of Menactra against all four vaccine serogroups, with regard to seroresponse/seroprotection rates, and GMTs 1 month after vaccination. Moreover, an exploratory arm of one of these studies suggested Menveo was at least as immunogenic as Menomune in adults aged 56-65 years. Longer term, the immunogenicity of Menveo persisted for 12-22 months post-vaccination in the adolescent studies, with the vaccine generally remaining at least as immunogenic as Menactra or Menomune. Coadministration of Menveo with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine or Tdap and human papillomavirus vaccines generally did not affect the immunogenicity of these vaccines in adolescents and young adults in two additional randomized, single- or multicenter, phase III studies. The tolerability profile of Menveo was generally similar to that of the comparator vaccines Menactra or Menomune in adults and adolescents, and few Menveo recipients experienced serious adverse events within 30 days or 6 months post-vaccination.

Immune responses to meningococcal conjugate (Menactra; MCV-4) and plain polysaccharide (Menomune-A/C/Y/W-135; PSV-4) vaccines against serogroups A, C, Y, and W-135 were assessed in 220 of 1037 Chilean children aged 2 to 10 years participating in a comparative safety trial. Both vaccines were generally well tolerated. Geometric mean serum bactericidal antibody (SBA) titers 28 days postvaccination were comparable in both groups for all four serogroups. Seroconversion was evident in > 97% of MCV-4 and > 90% of PSV-4 vaccinees who tested seronegative at baseline. Menactra safely induced broad and robust immune responses against serogroups A, C, Y and W-135 in this population.