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H1N1 Monovalent Vaccine Approved in Switzerland NEW YORK -- November 13, 2009 -- The Swiss Agency for Therapeutic Products has approved a adjuvanted cell culture-based influenza A(H1N1) monovalent vaccine (Celtura) for the active immunisation of individuals aged 4 years and older and older against the H1N1 virus. Clinical trials conducted in more than 1,900 individuals evaluated the vaccine’s tolerability and immunogenicity. The studies showed that even with the lowest antigen content (3.75mcg), a single dose can induce immune responses associated with protection against H1N1 in children aged older than 3 years and in adults up to 40 years. Safety and tolerability profiles showed the cell culture-derived influenza vaccine had a similar safety profile to adjuvanted egg-based vaccines approved by the European Medicines Agency (EMEA). Local injection site (redness, swelling, and pain) and systemic complaints of mild fever, headache, and fatigue were the most frequent side effects reported and were of short duration. SOURCE: Novartis E-mail this page to a friend or colleague! To print, use this version