The Phase III study included 4,545 healthy infants in the U.S. and Latin America. The results, from the U.S. sites only, show that a high percentage (between 94% and 100%) of infants vaccinated with four doses at 2, 4, 6 and 12 months of age achieved robust immune responses against four meningococcal strains -- A, C, Y and W-135. Menveo was generally well tolerated, Novartis added, with similar safety profile to other infant vaccines.
Infants Are at the Greatest Risk
Meningococcal disease is a sudden, unpredictable, serious and often deadly disease. It is a leading cause of bacterial meningitis -- an infection of the membrane around the brain and spine -- and sepsis -- a bloodstream infection. Infants under one year old are at greatest risk because the highest rates occur early in the first year of life. Up to 10% of children in that age group who contract meningococcal disease die. Currently, no broad-coverage vaccine is licensed for infants.
Based on the study, Novartis now plans to file for an application of a broader use of the vaccine with the U.S. Food and Drug Administration by year-end. Menveo is approved in the U.S. for use in those 11 to 55 years old. The FDA is also currently reviewing Menveo for children 2 to 10 years old.
Globally, more than 500,000 cases of meningococcal disease occur each year, leading to more than 50,000 deaths.
Novartis shares climbed half a percent in morning trading.