Novartis Vaccines said that FDA also has recently accepted for review a separate sBLA which includes data describing the persistence of meningococcal antibodies in adolescents 22 months postvaccination.
Menveo is a quadrivalent meningococcal conjugate vaccine that was licensed by the FDA in February 2010 for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 11-55 years of age. Menveo does not prevent N. meningitidis serogroup B infections.
Reportedly, the pediatric supplemental application is supported by Phase III trial data. The trial was stratified into two age subsets — 2-5 years of age and 6-10 years of age. A total of 2,907 study participants were randomised to receive a single dose of Menveo, a single dose of its comparator (the other currently US-licensed ACWY meningococcal conjugate vaccine) or two doses of Menveo.
The study measured, for each of the four serogroups, both the percentage of subjects who achieved an immune response as measured by seroresponse, and the proportion of subjects achieving human serum bactericidal antibody (hSBA) titers greater than or equal to 1:8. Additionally, the study examined functional antibody level as measured by geometric mean titers (GMT).
Novartis Vaccines stated that the antibody persistence data were collected from a separate Phase III study in adolescents. This trial included a total of 597 participants who were randomised to receive either Menveo or the comparator (the other currently US-licensed ACWY meningococcal conjugate vaccine), or were enrolled as naive controls.
The primary objective was to assess the persistence of circulating meningococcal antibodies a median of 22 months postvaccination for meningococcal serogroups A, C, Y and W-135 using hSBA, expressed as the proportions of subjects with a titer greater than or equal to 1:8 and GMTs.
The Menveo development program continues in multiple Phase III clinical trials. Menveo has the potential to be utilised in a broad age range, and the company plans to seek supplementary licensures for use of the vaccine in other age groups. Novartis expects to file data to support an infant indication in 2011.