Phase Ⅱ Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

PCV24 (low-dose 1) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, and the dosage is 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows: 4.0 μg per vial for serotypes 3, 6B, and 12F; and 2.0 μg per vial for the other 21 serotypes, namely 1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. After binding to carrier proteins, the polysaccharides of each serotype are adsorbed on an aluminum phosphate adjuvant (aluminum content: 0.125 mg per dose).

"PCV24 (low-dose 2) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, with a dosage of 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows:~3 types (3, 6B, 12F): 4.0 μg per vial 21 other serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F): 2.0 μg per vial After binding to carrier proteins, the polysaccharides of each serotype are adsorbed on an aluminum phosphate adjuvant with an aluminum content of 0.25 mg per dose."

"PCV24 (high-dose) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, with a dosage of 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows:~3 types (3, 6B, 12F): 8.0 μg per vial 21 other serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F): 4.0 μg per vial After binding to carrier proteins, the polysaccharides of each serotype are adsorbed on an aluminum phosphate adjuvant with an aluminum content of 0.25 mg per dose."

PPV23 produced by Chengdu Institute of Biological Products is a formulation with each vial containing 0.5 ml, and the dosage is 0.5 ml per person per administration. It contains polysaccharides of the following pneumococcal serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F, with each serotype containing 25 μg of polysaccharide. In addition, it contains sodium chloride and water for injection.