PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

November 18, 2023

Primary Completion Date

June 15, 2024

Study Completion Date

July 30, 2024

Conditions
Streptococcus Pneumoniae Pneumonia
Interventions
BIOLOGICAL

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)."

BIOLOGICAL

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)."

BIOLOGICAL

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."

BIOLOGICAL

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."

Trial Locations (1)

210000

Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing

All Listed Sponsors
lead

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

NCT07025876 - PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine | Biotech Hunter | Biotech Hunter