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Novartis meningitis vaccine performs well

Novartis' vaccine Menveo has provided robust immunogenicity in infants against four major serogroups of meningococcal disease in phase III trials

Menveo (meningococcal group A, C, W135 and Y conjugate vaccine) offers infants protection against four strains of meningococcal disease, according to phase III trial data presented orally at the 48th annual meeting of the Infectious Disease Society of America (IDSA), held October 21-24 in Vancouver, Canada. In light of these positive results, Menveo has the potential to become the first quadrivalent meningococcal vaccine for infants.

Together, serogroups A, C, W135 and Y cause the majority of meningococcal disease cases in the US, Africa, and the Middle East. The four strains are also present in Europe, Asia and Latin America and represent a significant threat, as there is currently no approved vaccine for the highest-risk patient population: infants under 12 months of age.

This trial assessed the safety and efficacy of Menveo against four serogroups of meningococcal disease in infants from two months of age. The randomised, open-label, multicentre, parallel-group trial included more than 4,500 healthy infant participants throughout the US and Latin America (though only data from the US sites was presented at IDSA). The vaccine was administered at 2, 4, 6 and 12 months, both alone and in combination with other paediatric vaccines (DTaP, IPV, HBV, Hib, pneumococcal). 

Menveo was shown to provide immune protection against meningococcal serogroups A, C, W135 and Y in a high percentage of infants vaccinated from two months of age. For serogroup A, 94 per cent of vaccinated infants achieved a protective immune response one month after the final dose; for serogroup C, 98 per cent, and for serogroups W135 and Y, 100 per cent. The vaccine was well tolerated when administered either as monotherapy or in combination with other paediatric vaccines.

Menveo is currently indicated for active immunisation to prevent invasive meningococcal disease caused by serogroups A, C, W135 and Y in individuals 11-55 years of age in the US, Chile, Argentina, and individuals 11 years of age and older in the EU, Peru, Indonesia, Malaysia, Australia, Canada and Pakistan. Menveo is also being evaluated in 24 completed and ongoing studies, 16 of which are in infants and toddlers, and eight in adolescents and adults.

However, based on these newly presented phase III results, Novartis now intends to submit a supplemental Biologics Licence Application (sBLA) to the US Food and Drug Administration (FDA) by the end of the year. If approved, Menveo will be the only meningococcal quadrivalent conjugate vaccine that could be administered to infants of two months of age and older. The company also plans to submit additional data to the European Medicines Agency (EMA) to support the use of Menveo in infants of two months to two years of age, as well as in children of two to 10 years of age.

25th October 2010

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