Novartis has reported positive Phase III study results for Menveo, a vaccine indicated for the prevention of invasive meningococcal disease.

The randomised, open-label, multi-centre and parallel-group study, which enrolled more than 4,500 infants.

It revealed that a high percentage of infants vaccinated with four doses of Menveo achieved immune responses against meningococcal serogroups A, C, W135 and Y.

Menveo was generally well-tolerated when administered alone or in combination with other paediatric vaccines.

The study was conducted in the US and Latin America, in which infants were randomised in a two-to-one ration to receive routine infant vaccinations alone or in combination with Menveo at two, four, six and 12 months of age.

Novartis plans to submit a supplemental biologics licence application to the US Food and Drug Administration by the end of 2010, followed by submissions in Europe and rest of the world.

Meningococcal disease is the leading cause behind bacterial meningitis and sepsis, which can result in side-effects such as brain damage, learning disabilities, hearing loss and limb loss.