240
Participants
Start Date
November 18, 2023
Primary Completion Date
June 15, 2024
Study Completion Date
July 30, 2024
low dose PCV24
"The 24-valent pneumococcal polysaccharide conjugate vaccine (low-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 serotypes (3, 6B, 12F): 4.0 μg per vial each~* 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 each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose)."
high dose PCV24
"The 24-valent pneumococcal polysaccharide conjugate vaccine (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 serotypes (3, 6B, 12F): 8.0 μg per vial each 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 each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose)."
PPV23
"The 23-valent pneumococcal polysaccharide vaccine (PPV23) produced by Chengdu Institute of Biological Products is available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration. It contains the following pneumococcal polysaccharides for each serotype:~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: 25 μg per vial for each serotype.~Additionally, it contains sodium chloride and water for injection."
Placebo
"In addition to the antigen components, the 24-valent pneumococcal polysaccharide conjugate vaccine developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. contains the following excipients:~Aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose) Sodium chloride Succinic acid Polysorbate 80 Water for injection It is a liquid formulation, available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration."
Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing
Jiangsu Province Centers for Disease Control and Prevention
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