Novartis announced that the FDA has approved Menveo (meningococcal [Groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children 2–10 years of age. This approval was based on data from a Phase 3 trial involving 5,297 children 2–10 years of age. In the pivotal trial, the safety and immunogenicity of Menveo against each of the four serogroups were compared with those of the other currently US-licensed ACW-135Y meningococcal conjugate vaccine.
Menveo was initially approved in February 2010 for the active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11-55 years of age.
For more information call (877) 683-4732 or www.menveo.com.