Novartis announced that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A/H1N1 2009 monovalent vaccine, Celtura.

Celtura is an MF59 adjuvanted inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by the novel pandemic A/H1N1 influenza virus. The vaccine contains 3.75 micrograms of antigen and 0.125 ml of MF59.

Clinical studies conducted with more than 1,850 subjects evaluated Celtura's tolerability and immunogenicity. The studies showed that even with the lowest antigen content ( 3.75 microg ) a single Celtura dose can induce immune responses associated with protection against influenza in individuals from 3 to 50 years of age. Safety and tolerability profiles were as expected. Local injection site ( redness, swelling and pain ) and systemic complaints of mild fever, headache and fatigue were the most frequent side effects reported.

Celtura uses a validated cell culture line for production of viral antigen components rather than traditional chicken eggs. The technology has previously been licensed in Europe for the production of the seasonal flu vaccine, Optaflu.

MF59 is an adjuvant with an established safety profile supported by more than 12 years of clinical safety data in Europe and more than 45 million doses of commercial use in the influenza vaccine Fluad ( licensed in Europe but not the US ).

Source: Novartis, 2009

XagenaMedicine2009


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