[Translation] A randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above
主要目的:(1)评价 2 岁及以上健康人群接种 23价肺炎球菌多糖疫苗后,其疫苗血清型特异性肺炎球菌1gG抗体水平非劣效于相同免疫程序接种的同类对照疫苗;(2)评价2岁及以上健康人群接种23价肺炎球菌多糖疫苗的安全性。
次要目的:评价 2 岁及以上健康人群接种 23 价肺炎球菌多糖疫苗后的免疫持久性。
[Translation] Primary objectives: (1) To evaluate the non-inferiority of the vaccine serotype-specific pneumococcal 1gG antibody level after 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above compared with the same control vaccine administered during the same immunization schedule; (2) To evaluate the safety of 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
Secondary objectives: To evaluate the immune persistence after 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.