Novartis Bexsero pivotal study data on meningococcal serogroup B presented at ESPID

New data from a pivotal study in more than 1,800 infants show that Novartis candidate vaccine Bexsero® (Multicomponent Meningococcal Serogroup B Vaccine) induces a robust immune response to meningococcal serogroup B when given alone or when co-administered with other routine vaccines. These results also show that Bexsero can fit into various vaccination schedules in the first year of life, when the likelihood of contracting this often-deadly disease is greatest. The study also demonstrated that Bexsero has an acceptable tolerability profile.

Data from another pivotal study in more than 1,500 toddlers shows that Bexsero provides protective immune response when used as a booster in toddlers already primed, or after two doses in those not previously vaccinated with Bexsero. A third study presented showed that Bexsero induces a strong immune response in adolescents against meningococcal serogroup B (MenB). The data were presented at The European Society for Paediatric Infectious Diseases (ESPID) in The Hague, The Netherlands.

These data are included in the comprehensive clinical program with Bexsero in more than 8,000 infants, toddlers, adolescents and adults which served as the basis of the registration file submitted to the European Medicines Agency (EMA) in December 2010.

MenB is the most common cause of bacterial meningitis for which there is no effective routine vaccine, and it is responsible for up to 80% of meningococcal cases in infants under one year of age in Canada and 68 per cent of the cases in adolescents. Survivors may suffer permanent brain damage, learning disabilities, hearing loss, and limb loss.

"The serious and long-term effects of MenB are often devastating to its victim, family members and the community at large," said Jamie Findlow PhD, Deputy Head of the Health Protection Agency, Vaccine Evaluation Unit, Manchester, UK. "The rapid disease progression and flu-like symptoms of MenB can be difficult to recognize, particularly in infants, making prevention through vaccination the most effective way to control this disease."



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