Meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo): A vaccine indicated for active immunization to prevent invasive meningococcal disease

April 1, 2011

New molecular entity: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine was approved by FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years.

A vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years

In January 2011, meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo) was approved by FDA to prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years. The vaccine results in the production of antibodies directed against the capsular polysaccharides of serogroups A, C, Y, and W-135. The presence of such antibodies has been shown to be protective against the development of invasive meningococcal disease. Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine does not prevent N. meningitidis serogroup B infections.

Efficacy. The efficacy of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine in subjects aged 2 to 55 years was assessed by comparing the serum bactericidal antibody (SBA) responses to immunization with meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine to those following immunization with FDA-approved meningococcal quadrivalent conjugate vaccine Menactra (Sanofi Pasteur) in 2 randomized, multicenter, clinical trials. In both trials, the primary end point was hSBA seroresponse for all 4 serogroups (A, C, Y, and W-135) at 28 days after vaccination. For the age groupings of 6 to 10 years (n=1,092), 11 to 18 years (n=1,434). and 19 to 55 years (n=1,312), non-inferiority of Menevo to Menactra for the proportion of subjects with a seroresponse was demonstrated for each of the 4 serogroups. In 2 to 5 year olds (n=1,217), non-inferiority of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine to Menactra for the proportion of subjects with a seroresponse was demonstrated for serogroups C, W-135, and Y, but not for serogroup A.

Dosing. Use of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine requires the reconstitution of a MenA lyophilized conjugate vaccine component with a MenCYW-135 liquid conjugate vaccine component immediately before administration. Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine is administered as a single 0.5 mL intramuscular injection, preferably into the deltoid muscle. For children aged 2 to 5 years at continued high risk of meningococcal disease, a second dose may be administered 2 months after the first dose.