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15-VALENT VACCINE COMPOSITION BASED ON PNEUMA-COCK POLYSACCHARIDE-PROTEIN CONJUGATE
专利权人:
МЕРК ШАРП ЭНД ДОМЭ КОРП. (US)
发明人:
КОЛФИЛД Майкл Дж. (US),АЛ Патрик Л. (US),БЛЮ Джеффри Т. (US),КЭННОН Джейм Л. (US)
申请号:
RU2012138368/15
公开号:
RU2012138368A
申请日:
2011.02.03
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. An immunogenic composition comprising: (1) a multivalent mixture of polysaccharide conjugates with a protein, consisting of capsular polysaccharides of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V14, 18C, 19A, 19F, 22F, 23F and 33F, carrier protein conjugated; and (2) a pharmaceutically acceptable carrier. 2. The immunogenic composition of claim 1, wherein the carrier protein is CRM. 3. The immunogenic composition of claim 1, further comprising an adjuvant. The immunogenic composition of claim 2, wherein the adjuvant is an aluminum-based adjuvant. The immunogenic composition according to claim 4, wherein the adjuvant is selected from the group consisting of aluminum phosphate, aluminum sulfate and aluminum hydroxide. The immunogenic composition of claim 5, wherein the adjuvant is aluminum phosphate. The immunogenic composition according to claim 1, in the form of a single 0.5 ml dose containing 2 μg of each saccharide, with the exception of 4 μg for 6B; approximately 32 μg CRM carrier protein; 0.125 mg of elemental aluminum adjuvant (0.5 mg of aluminum phosphate); 150 mM sodium chloride and 20 mM L-histidine buffer. 8. A method of inducing an immune response to a capsular polysaccharide, comprising administering to a person an immunologically effective amount of an immunogenic composition according to claim 1.9. The method of claim 8, where the immunogenic composition is administered in a single 0.5 ml dose, formulated so that it contains 2 μg of each saccharide, with the exception of 4 μg for 6B; approximately 32 μg CRM carrier protein; 0.125 mg of elemental aluminum adjuvant (0.5 mg of aluminum phosphate); 150 mM sodium chloride and 20 mM L-histidine buffer.1. Иммуногенная композиция, содержащая:(1) поливалентную смесь конъюгатов полисахаридов с белком, состоящую из капсульных полисахаридов серотипов 1, 3, 4, 5, 6A, 6B, 7F, 9V14, 18C, 19A, 19F, 22F, 23F и 33F, конъюгированных с белком-носителем; и(2) фармацевтически приемлемый носитель.2. Иммуногенная композиция по п.1
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