The P-III trial evaluated MenABCWY in 2431 healthy adolescents & young adults aged 10 through 25yrs. with IMD across US & EU
The trial met 1EPs & 2EPs i.e., the vaccine was well-tolerated with an acceptable safety profile, and immunogenicity was non-inferior to licensed vaccines (2 doses of Trumenba & 1 dose of Menveo) for 5 meningococcal serogroups
A single dose of MenABCWY met the non-inferiority criteria over 1 dose of Menveo, patients who received 2 doses of MenABCWY showed greater immune responses with ≥4-fold increases against 4 serogroup B viruses over licensed vaccines. The company plans to submit an application to the US FDA for approval of the vaccine in Q4’22 7 & is also being planned outside the US
Ref: Businesswire | Image: Pfizer
