New Phase III data indicate that Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) demonstrated robust immunogenicity in infants potentially offering protection against four major serogroups of meningococcal disease. These data were presented during an oral presentation at the 48th annual meeting of the Infectious Disease Society of America (IDSA) held in Vancouver, Canada.
This pivotal trial, including more than 4,500 infants worldwide, met its primary endpoints. Results show that a high percentage of infants vaccinated with four doses achieved robust immune responses against meningococcal serogroups A, C, W135 and Y. Menveo was generally well tolerated when given either alone or co-administered with other pediatric vaccines. Menveo has the potential to be the first meningococcal quadrivalent conjugate vaccine that induces high levels of protective antibodies against serogroups A, C, W135 and Y in infants vaccinated from 2 months of age. Infants under one year of age are at greatest risk for meningococcal disease and currently no broad-coverage vaccine is licensed for this population.
“In my practice I have seen the devastating effects of meningococcal disease in infants,” said Stan Block, MD, FAAP, an investigator for the study. “Meningococcal vaccines are being developed that can provide broad protection against the disease in this vulnerable population.”
Menveo has the potential to fulfill an unmet medical need as a vaccine that can help protect people, from early infancy to adulthood, against four major causes of meningococcal disease (serogroups A, C, W135 and Y), a sudden, unpredictable and often life-threatening illness. Together these four serogroups cause the majority of meningococcal disease cases in the United States (US), Africa, and the Middle East and are also present in Europe, Asia and Latin America.
“As the most vulnerable age group, infants should be directly protected from this unpredictable and devastating disease,” said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics.
“These data are another step in the significant progress Novartis is making toward our goal of protecting all age groups against meningococcal disease.”
In the US, Novartis intends to submit a supplemental Biologics License Application (sBLA) based on these pivotal data to the US Food and Drug Administration (FDA) by year-end. If approved, Menveo will be the only meningococcal quadrivalent conjugate vaccine that could be administered to infants 2 months of age and older. This label claim extension will be also submitted in Europe and in other parts of the world.