The US Food and Drug Administration (FDA) has approved Novartis' Menveo, a vaccine to prevent against invasive meningococcal disease.
The quadrivalent meningococcal conjugate vaccine was approved for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people aged 11 to 55 years old.
Meningococcal disease infects more than 500,000 people each year, leading to more than 50,000 deaths globally with as many as one in seven patients who contract the disease dying from it.
Novartis' vaccines and diagnostics division head Andrin Oswald said that FDA approval of Menveo is an important milestone for adolescent immunisation in the US.
"Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents," Oswald said.
Approval of Menveo was based on a Phase III head-to-head clinical trial comparing Menveo to the other US-licensed ACWY meningococcal conjugate vaccine among subjects aged 11 to 55 years old.
The trial was broken into two subsets consisting of adolescents, aged 11 to 18, and adults, aged 19 to 55. It measured for each of the four serogroups, including both the percentage of subjects who achieved an immune response as measured by seroresponse, and proportions achieving human serum bactericidal antibody. In addition, antibody levels were examined in the study as measured by geometric mean titers.