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news.Novartis' Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) Phase III randomised, open-label, multi-center, parallel-group study met its primary endpoints.
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Menveo showed immunogenicity in infants potentially offering protection against four major serogroups of meningococcal disease.
Menveo was generally well tolerated when given either alone or co-administered with other pediatric vaccines.
In the trial, 67% of the infants have achieved a protective immune response in serogroup A, 97% for serogroup C, and 96% for serogroups W135 and Y when measured at 7 months of age, one month after the third dose.
One month after the fourth dose at 12 months of age, the percentages were 94% for serogroup A, 98% for serogroup C, and 100% for serogroups W135 and Y.
Novartis Vaccines and Diagnostics division head Andrin Oswald said that these data are another step in the significant progress Novartis is making toward the 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 by year-end.