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Novartis Reports Positive Findings From Pivotal Phase III Trial Of Bexsero

Novartis International AG (NVS) announced that findings from a pivotal Phase III clinical trial of Bexsero involving 3,630 infants from two months of age showed that the MenB vaccine demonstrated a protective immune response, and has an acceptable safety profile when administered as a three-dose primary series concomitantly with routine vaccines. A robust booster response was observed in toddlers to a fourth dose administered at 12 months, which may contribute to an extended duration of protection.

Upon regulatory approval, Bexsero, an investigational multicomponent meningococcal group B vaccine, will be the first licensed vaccine with the potential to protect against a broad range of strains that cause MenB disease worldwide. The company said the tolerability profile and immunogenicity of Bexsero have been established through a clinical program including data from large Phase II/III clinical trials involving almost 8,000 patients, including infants.

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