[Translation] A single-center, randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate the safety and immunogenicity of freeze-dried group AC meningococcal conjugate vaccine
评价冻干AC群脑膜炎球菌结合疫苗应用于2月龄~11月龄婴儿的安全性和免疫原性。主要目的为评价冻干AC群脑膜炎球菌结合疫苗在2月龄~11月龄婴儿中接种的安全性和接种冻干AC群脑膜炎球菌结合疫苗后的抗体阳转率和4倍效价增高情况。次要目的为评价2月龄~11月龄婴幼儿免疫前后血清中抗AC群脑膜炎球菌荚膜多糖的抗体水平。
[Translation] To evaluate the safety and immunogenicity of freeze-dried group AC meningococcal conjugate vaccine in infants aged 2 to 11 months. The primary objective was to evaluate the safety of freeze-dried group AC meningococcal conjugate vaccine in infants aged 2 to 11 months and the antibody seroconversion rate and 4-fold titer increase after vaccination with freeze-dried group AC meningococcal conjugate vaccine. The secondary objective was to evaluate the level of antibodies against group AC meningococcal capsular polysaccharides in the serum of infants aged 2 to 11 months before and after immunization.