Novartis receives regulatory approval in Germany for cell culture-based Influenza A(H1N1) pandemic vaccine
Novartis announced that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland.
Celtura is manufactured in Marburg, Germany and 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 (ug) of antigen and 0.125 ml of MF59®. It will be offered in multi-dose vials and in single-dose pre-filled syringes.
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 ug) 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.
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