The person depicted is a model used for illustrative purposes only.
Watch the MENVEO Clinical Study Design Video
The immunogenicity of MENVEO was evaluated 1 month after vaccination in a pivotal noninferiority trial that compared MENVEO with Menactra. The primary endpoint was the percentage of subjects with a seroresponse 1 month after a dose of either MENVEO or Menactra.1
Seroresponse was defined as:
For all 4 serogroups (A, C, W-135, and Y), noninferiority criteria for MENVEO compared to Menactra were met.1
MENVEO does not prevent N. meningitidis serogroup B infections.
SERORESPONSE RATES AT 1 MONTH POSTVACCINATION IN ADOLESCENTS 11-18 YEARS OF AGE1,*
SEE THE RELATIVE GMT RATES VS MENACTRA1
This head-to-head study also measured geometric mean titers (GMTs) in subjects 1 month after a dose of either MENVEO or Menactra in 11 to 18 year-olds. GMTs are a measure of the level of immune response to a vaccine in a specific study group.1
The point estimates for fold differences in GMTs between MENVEO and Menactra are >1 for all 4 serogroups, although for serogroup C the confidence interval includes 1. The clinical significance of these differences is unknown.1
GMTs AT 1 MONTH POSTVACCINATION IN ADOLESCENTS 11-18 YEARS OF AGE1,†
CI=confldence interval; GMT=geometric mean titers; hSBA=serum bactericidal assay with exogenous human complement source.
|*||Seroresponse was defined as a postvaccination hSBA ≥1:8 for subjects with a prevaccination hSBA <1:4, or at least a 4-fold increase higher than baseline titers for subjects with a prevaccination hSBA ≥1:4.|
|†||GMTs are a measure of the level of immune response to a vaccine in a specific study group. GMTs for MENVEO were evaluated at 1 month postvaccination.|
Randomized, multicenter, active-controlled study in healthy adolescents 11-18 years of age. Subjects were randomized to receive 1 dose of MENVEO or Menactra. Noninferiority criterion for the primary endpoint was met for all serogroups (lower limit of the 2-sided 95% CI ≥10% for vaccine group differences [MENVEO minus Menactra]). In separate studies, for the proportion of subjects with a seroresponse, noninferiority criterion was met for serogroups C, W-135, and Y but not for serogroup A in subjects 2-5 and 6-10 years of age, and was met for all serogroups in subjects 19-55 years of age.
MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. MENVEO is approved for use in persons 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.