IMMUNOGENICITY IN ADOLESCENTS


ARE YOUR PATIENTS MISSING THEIR MENACWY BOOSTER VACCINATION?

According to
2021 CDC Survey Data

According to the CDC, in 2021, 40% of 17-year-olds had not received a booster dose of a meningitis ACWY vaccine

of 17-year-olds had not received a booster dose of a meningitis ACWY vaccine.1


Seroresponse rates for MENVEO in adolescent patients

The immunogenicity of MENVEO was evaluated in a pivotal trial that compared MENVEO with Menactra. The primary endpoint was noninferiority for the proportion of subjects with a seroresponse across serogroups 28 days after a dose of either MENVEO or Menactra.2


Seroresponse Rates at 28 Days Postvaccination in Adolescents Aged 11-18 Years2

MENVEO 2-vial presentation: Seroresponse Rates at 28 Days Postvaccination in Adolescents Aged 11-18 Years
MENVEO 2-vial presentation: Seroresponse Rates at 28 Days Postvaccination in Adolescents Aged 11-18 Years

Seroresponse was defined as2:

  • A postvaccination hSBA ≥1:8 for subjects with a prevaccination hSBA <1:4 or
  • At least a 4-fold increase above baseline titers for subjects with a prevaccination hSBA ≥1:4

For all 4 serogroups (A, C, W-135, and Y), noninferiority criteria for MENVEO compared to Menactra were met.2,*

MENVEO does not prevent N. meningitidis serogroup B infections.2

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 11-18 and 19-55 years of age. The clinical significance of these differences is unknown.2

Relative GMT Rates vs Menactra

This head-to-head study also measured GMTs in subjects 28 days 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.2

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.2

GMTs at 28 Days Postvaccination in Adolescents Aged 11-18 Years2

MENVEO 2-vial presentation: GMTs at 28 Days Postvaccination in Adolescents Aged 11-18 Years
MENVEO 2-vial presentation: GMTs at 28 Days Postvaccination in Adolescents Aged 11-18 Years

Study Design

Randomized, multicenter, active-controlled study in healthy adolescents 11 through 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]).2

Vaccination may not protect all recipients.


CI=confidence interval; GMT=geometric mean titer; hSBA=human serum bactericidal assay.