【摘要】 在现行的A群脑膜炎球菌多糖原液制造工艺的基础上 ,经部分改进后进行C群脑膜炎球菌多糖原液的生产。 3批中试A +C群脑膜炎球菌多糖疫苗经全面检定后 ,各项指标均符合WHO《生物制品规程》的要求。该疫苗在接种人体后 ,5～ 13岁儿童组 ,抗A群及抗C群脑膜炎球菌的血清杀菌抗体 4倍增长率为 96 5 9%和 92 15 % ;≤2岁儿童组 ,抗A群及抗C群脑膜炎球菌的血清杀菌抗体 4倍增长率为 6 8 6 0 %和 6 9 77%。 2组儿童接种后 1个月的抗A群及抗C群膜炎球菌血清杀菌抗体几何平均滴度 (GMT )与接种前均有显著性差异 (P <0 0 0 1)更多还原

【Abstract】 The group C Meningococcal polysaccharide was made by partial improvement procedure of routine production of group A Meningococcal polysaccharide 3 lots of real scale group A+C Meningococcal polysaccharide vaccine have been produced and all tests results were in accordance with the WHO requirement of biolgical substance.Two age groups of children were inoculated by this vaccine,the 4 fold increase rate of bactericidal antibody to group A and group C Meningococci were 96.59% and 92.15% in 5～13 years old children,the 4 fold increase rate of antibod to group A and group C Mengingococci were 68.60% and 69.77% in children under 2 years old respectively.The difference of geometric mean titer of bactericidal antibody to group A and group C Mengingococci were significant(P<0.001) between after and before inoculation in two age groups respectively.更多还原