Novartis International AG (NYSE:NVS) said Monday that phase III results for Menveo, a vaccine for meningococcal disease, indicate strong immune responses in infants.
Meningococcal disease is a leading cause of bacterial meningitis - an infection of the membrane around the brain and spine - and sepsis - a bloodstream infection. Survivors of meningococcal disease may experience side effects, such as brain damage, learning disabilities, hearing loss and limb loss.
According to the US Centers for Disease Control and Prevention, there are two incidence peaks of meningococcal disease, with the highest rates in the first year of life and the other in adolescence. Globally, there are more than 500,000 cases of meningococcal disease each year, leading to more than 50,000 deaths.
The phase III study, which included more than 4,500 infants in trial sites throughout the US and Latin America, met its primary endpoints of assessing the safety and tolerability of the vaccine.
The company said that results show that a high percentage of infants vaccinated with four doses achieved "robust immune responses" against meningococcal bacteria groups A, C, W135 and Y.
One month after the fourth dose at 12 months of age, 94% of infants achieved a protective immune response for serogroup A, 98% for serogroup C, and 100% for serogroups W135 and Y.
In addition, the vaccine was well tolerated, said Novartis, when given either alone or co-administered with other pediatric vaccines.
According to the company, Menveo has the potential to be the first meningitis vaccine that protects against four different causes of the disease in infants vaccinated from two months of age.
The four different types of bacteria that Menveo protects against cause the majority of meningococcal disease cases in the United States, Africa, and the Middle East and are also present in Europe, Asia and Latin America.
Novartis intends to submit a supplemental Biologics License Application (sBLA) based on this data to the US FDA by year-end. If approved, the label claim extension will also be submitted in Europe and in other parts of the world, it said.
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