Patent ID: 9566326
Date: 2017-02-14
CPC Classifications: A61K,A61P,C12N

Claim:
1. A composition in unit dosage form, wherein: the composition comprises (i) an influenza B virus strain antigen and (ii) an adjuvant; and the unit dosage has a volume of less than 0.5 mL and contains between 6-9 μg of hemagglutinin per influenza virus strain, wherein the adjuvant comprises an oil-in-water emulsion in which the majority of oil droplets have a diameter of less than 1 μm and the oil droplets comprise squalene; and wherein the composition is immunogenic in that when administered to a pediatric population of at least 50 children between 6 and 36 months of age, the composition will elicit efficacy that satisfies one or more of the following criteria: (i) ≧70% seroprotection; (ii) ≧40% seroconversion or significant increase; and/or (iii) a geometric mean titer increase of ≧2.5-fold.