DOSE VOLUME OF IMMUNOGENIC INFLUENZA PREPARATION FOR HUMAN USE AND VACCINE COMPRISING THE SAME, METHODS FOR PREPARING THEM AND USE THEREOF FOR THE TREATMENT OR PREVENTION OF DISEASES CAUSED BY INFLUENZA VIRUS IN HUMANS

摘要

The present invention provides an immunogenic influenza composition in a dose volume suitable for human use at an amount of 0.2. to 1.5 mL, comprising an influenza virus antigen or antigenic preparation comprising 15 μg or less than 15 μg haemagglutinin (HA) per influenza virus strain, in combination with an adjuvant of an oil-in-water type emulsion, wherein wherein the adjuvant comprises: (1) 5-6 mg squalene, 2-3 mg emulsifying agent and 5-7 mg tocol per human dose; (2) 2-3 mg squalene, 1-1.5 mg emulsifying agent and 2.5-3.5 mg tocol per human dose; or (3) 0.5-1.5 mg squalene, 0.25-0.75 mg emulsifying agent and 0.5-1.5 mg tocol per human dose. Further provided is a vaccine comprising the same. The dose volume of the preparation by the invention provides the antigen sparing and the reactogenicity reducing. Also provided are methods for the preparation of the dose volume and the vaccine and the use thereof for the treatment or prevention of diseases caused by influenza virus in humans.