See the immunogenicity in adolescents
See the seroresponse rates for MENVEO in adolescent patients
The immunogenicity of MENVEO was evaluated 28 days after vaccination in a pivotal noninferiority trial that compared MENVEO with Menactra. The primary endpoint was the percentage of subjects with a seroresponse 28 days after a dose of either MENVEO or Menactra.1
CI=confidence interval; hSBA=human serum bactericidal assay.
This head-to-head study also measured 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 are a measure of the level of immune response to a vaccine in a specific study group. GMTs for MENVEO were evaluated at 28 days postvaccination.1
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 years and 6-10 years of age, and was met for all serogroups in subjects 19-55 years of age.1 The clinical significance of these differences is unknown.