外文摘要：
An influenza vaccine adjuvanted with a sub-micron oil-in-water emulsion elicits significantly higher immune responses in human pediatric populations. Compared to an existing unadjuvanted pediatric influenza vaccine, the adjuvanted vaccines provided herein can induce in children a longer persistence of high serum antibody titers and also longer seroconversion and seroprotection. The improvement in immune responses is seen for both influenza A virus and influenza B virus strains, but it is particularly marked for influenza B virus. Moreover, while the existing vaccine provides poor immunity in children after a single dose, the adjuvanted vaccine provides high seroprotection rates against the influenza A virus H3N2 subtype even after a single dose. Furthermore, the adjuvanted vaccine offers significantly better seroprotection against mismatched strains of influenza A virus.NOVELTY - Composition in unit dosage form comprises: an influenza B virus strain antigen; an influenza A virus strain antigen; and an adjuvant. The unit dosage has a volume of less than 0.5 ml and contains 6-9 mu g of hemagglutinin per influenza virus strain. The adjuvant comprises an oil-in-water emulsion in which the majority of oil droplets have a diameter of less than 1 mu m and the oil droplets comprise squalene. The composition is immunogenic in that when administered to a pediatric population of at least 50 children of 6 and 36 months of age.USE - The composition is useful for raising an immune response to an influenza B virus strain in a human child of up to 72 months of age (claimed). Test details are described but no results given.
ADVANTAGE - The composition will elicit efficacy that satisfies at least one criteria comprising greater than or equal to 70% seroprotection, greater than or equal to 40% seroconversion or s! ignificant increase, and a geometric mean titer increase of greater than or equal to 2.5-fold (claimed).
主权项：Composition in unit dosage form comprises: an influenza B virus strain antigen; an influenza A virus strain antigen; and an adjuvant. The unit dosage has a volume of less than 0.5 ml and contains 6-9 mu g of hemagglutinin per influenza virus strain. The adjuvant comprises an oil-in-water emulsion in which the majority of oil droplets have a diameter of less than 1 mu m and the oil droplets comprise squalene. The composition is immunogenic in that when administered to a pediatric population of at least 50 children of 6 and 36 months of age. The composition will elicit efficacy that satisfies at least one criteria comprising greater than or equal to 70% seroprotection, greater than or equal to 40% seroconversion or significant increase, and/or a geometric mean titer increase of greater than or equal to 2.5-fold. An INDEPENDENT CLAIM is also include! d for a kit for preparing the immunogenic composition for use ! in immun izing a child of 6 and 36 months of age, comprising a first kit component comprising an influenza B virus strain antigen and an influenza A virus strain antigen, and a second kit component comprising the adjuvant, where the immunogenic composition, has a unit dose of 0.2-0.45 ml.
申请号：US201615395006
公开/公告号：US2017202955A1
申请日：2016-12-30
公开/公告日：2017-07-20
申请/专利权人：SEQIRUS UK LTD (SEQI-N)
发明/设计人：PODDA, A;GROTH, N;PELLEGRINI, M
分类号：A61K39/12; A61K39/145; A61K39/39; C12N7/00; A61K2039/545; A61K2039/55; A61K2039/55566; A61K2039/58; A61K2039/70; C12N2760/16134; C12N2760/16234
主分类号：A61K39/145; A61K39/39; C12N7/00
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