21-03-2013 дата публикации
Номер: US20130072881A1
An immunogenic composition comprising a plurality of capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to a carrier protein, and further comprising at least one preservative, preferably 2-phenoxyethanol (2-PE). The preservative-containing immunogenic compositions of the invention confer resistance to one or more micro-organisms and are useful for producing multi-dose vaccine formulations having advantageous properties with respect to long term stability of the different antigenic determinants in the immunogenic composition of choice. Related compositions and methods for measuring the efficacy of one or more preservatives in a vaccine formulation are also provided. 1Streptococcus pneumoniae. A multivalent immunogenic composition comprising a plurality of capsular polysaccharides from selected from the group consisting of serotypes 1 , 3 , 4 , 5 , 6A , 6B , 7F , 9V , 14 , 18C , 19A , 19F and 23F , wherein each of the capsular polysaccharides are separately conjugated to a carrier protein , and further comprising 2-phenoxyethanol (2-PE).2. The multivalent immunogenic composition of claim 1 , wherein said composition comprises seven or more capsular polysaccharides.3. The multivalent immunogenic composition of claim 1 , wherein said composition comprises 2-PE at a concentration of between 7 mg/mL and 15 mg/mL.4. The multivalent immunogenic composition of claim 3 , wherein said composition comprises 2-PE at a concentration of about 10 mg/mL.5. The multivalent immunogenic composition of claim 1 , wherein said composition comprises not less than 7 mg/mL of 2-PE.6. The multivalent immunogenic composition of claim 1 , wherein said composition comprises not less than 10 mg/mL of 2-PE.7. The multivalent immunogenic composition of claim 1 , wherein said composition comprises not less than 15 mg/mL of 2-PE.8. The multivalent immunogenic composition of claim 1 , wherein said composition further comprises an adjuvant claim 1 , ...
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