Novartis has presented promising late-stage data on its experimental meningococcal meningitis vaccine Menveo which could support a filing as soon as the second half of this year.

The Swiss drugmaker said that new Phase III data for Menveo, presented at the Pediatric Academic Societies meeting in Hawaii, show that the vaccine produced a greater immune response against meningococcal serogroups A, C, W-135 and Y (the four most common types) in adolescents aged 11-18 compared to Sanofi-Pasteur’s Menactra. In particular, the firm stated that for serogroup Y, among adolescents with low levels of immunity at the time of vaccination, 81% of subjects receiving Menveo generated a protective immune response versus 54% with Menactra.

Serogroup Y causes 39% of meningococcal disease cases in the USA, Novartis said, adding that infection with any of the four serogroups can lead to bacterial meningitis, an infection of the membrane around the brain and spinal cord, or sepsis. The Phase III trial, the first head-to-head study of Menveo and Menactra, assessed more than 2,100 patients who received a single vaccination with one of the two vaccines.

Novartis quoted Keith Reisinger, medical director at Primary Physicians Research in Pittsburgh, as saying that the data are encouraging because they show that Menveo may provide greater protection for the more than eight million infants and adolescents in the USA against these four vaccine-preventable serogroups than the currently available vaccine”. Novartis hopes to file the vaccine in the European Union and the USA this year but whether this data will be sufficient to get approval and take on Sanofi’s more established products remains to be seen.