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The inactivated influenza H1N1 vaccine is a monovalent, unadjuvanted biologic developed for the prevention of influenza caused by the 2009 pandemic H1N1 strain. Manufactured by Novartis Vaccines and Diagnostics and developed under the sponsorship of the National Institute of Allergy and Infectious Diseases (NIAID), this vaccine contains inactivated hemagglutinin antigens from the 2009 H1N1 influenza virus. It is administered intramuscularly as a 0.5 mL injection and was evaluated in clinical trials at dose levels of 15 mcg and 30 mcg. A notable Phase II randomized, open-label study (NCT00992433) assessed the safety and immunogenicity of this formulation in HIV-seropositive adults, stratified by CD4 count, to determine the optimal dosing regimen for immunocompromised populations during the pandemic.
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