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This drug refers to an experimental formulation of an adjuvanted, trivalent subunit influenza vaccine (aTIV) that underwent a Phase 1 clinical trial (NCT02126761). The formulation is characterized by modifications to the dosage levels of both the influenza virus antigens and the MF59 adjuvant. Specifically, the study investigated formulations where the MF59 adjuvant dosage was doubled or tripled, and/or the dosage of the three influenza virus strains was doubled, compared to a standard aTIV. The vaccine is designed to induce an immune response against influenza by presenting purified surface antigens (hemagglutinin and neuraminidase) from three different influenza virus strains, with the MF59 adjuvant enhancing the immune system's recognition and response. The primary indication for this vaccine is the prevention of influenza, particularly in elderly subjects aged 65 years and above, where it was evaluated for safety and immunogenicity.
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