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:
- 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.1
MENVEO does not prevent N. meningitidis serogroup B infections.
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
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.
- Prescribing Information for MENVEO.
- Pelton SI. Meningococcal disease awareness: clinical and epidemiological factors affecting prevention and management in adolescents. J Adolesc Health. 2010;46(2):S9-S15.
- Meningococcal vaccines for preteens, teens. Centers for Disease Control and Prevention website. http://www.cdc.gov/features/meningococcal/. Updated April 18, 2016. Accessed October 6, 2017.
- Meningococcal disease. In: Hamborsky J, Kroger A, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:231-245. http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed October 6, 2017.
- Slack R, Hawkins KC, Gilhooley L, Addison GM, Lewis MA, Webb NJA. Long-term outcome of meningococcal sepsis-associated acute renal failure. Pediatr Crit Care Med. 2005;6(4):477-479.
- Vyse A, Anonychuk A, Jäkel A, Wieffer H, Nadel S. The burden and impact of severe and long-term sequelae of meningococcal disease. Expert Rev Anti Infect Ther. 2013;11(6):597-604.
- MacNeil J, Cohn A. Meningococcal disease. In: Roush SW, Baldy LM, eds. Manual for the Surveillance of Vaccine-Preventable Diseases. 5th ed. Atlanta, GA: Centers for Disease Control and Prevention; 2011. http://www.cdc.gov/vaccines/pubs/surv-manual/chpt08-mening.pdf. Accessed October 6, 2017.
- Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
- Centers for Disease Control and Prevention website. Active bacterial core surveillance report, emerging infections program network, Neisseria meningitidis, 2005-2014. http://www.cdc.gov/abcs/reports-findings/surv-reports.html. Accessed October 6, 2017.
- Pichichero ME. Booster vaccinations: can immunologic memory outpace disease pathogenesis? Pediatrics. 2009;124(6):1633-1641.