FIELD: pharmacy.
SUBSTANCE: invention can be used to treat or prevent an infection caused by group B streptococcus. Immunogenic composition containing conjugates of polysaccharide-carrier protein are proposed, in which each of the conjugates includes a capsular polysaccharide from a different serotype of group B streptococcus (GBS) conjugated with a carrier protein, and serotypes include serotypes Ia, Ib, II, III, IV and V, the capsular polysaccharide in each conjugate has a sialic acid level of more than 60%, and the carrier protein contains CRM197. While the immunogenic composition additionally contains sodium chloride at a concentration of 150 mm or higher, polysorbate-80, histidine, and optionally an adjuvant, which is aluminum phosphate. The pH of the immunogenic composition is between 6.5 and 7.5 and the immunogenic composition does not elicit a reduced immune response to the III serotype.
EFFECT: stable hexavalent immunogenic formulation.
13 cl, 47 dwg, 51 tab, 26 ex
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Authors
Dates
2023-03-09—Published
2017-11-02—Filed