Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older . The objective of the study is to evaluate the safety and tolerability of PCV24. The trial is a single-center, randomized, blind,parallel-controlled design I clinical trial.
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The objective of the study is to evaluate the safety and tolerability of PCV24. The active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products. The placebo is aluminum phosphate adjuvant (aluminum content 0.25mg/dose), sodium chloride, succinic acid, polysorbate 80, and water for injection except for antigen components in 24-valent pneumococcal polysaccharide conjugate vaccine developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Vinorelite Biopharmaceutical Co., Ltd. A total of at least 240 participants will be enrolled, including 84 adults aged 18-60years and 120 elderly people aged ≥61 years. Participants will be randomized in a 1:1:1:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PPSV23 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
One dose of Reinovax PCV24 formulation 1(0.5mL)
One dose of Reinovax PCV24 formulation 1(0.5mL)
One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.
Zhenjiang Center for Disease Control and Prevention
Zhenjiang, Jiangsu, China
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Time frame: 0-7days after vaccination
incidence of adverse events
The incidence of adverse events within 30 days after vaccination.
Time frame: 0~30 days after vaccination.
Incidence of serious adverse events (SAE)
Incidence of SAE during the period of safety monitoring
Time frame: 0-6 months after vaccination
Incidence of clinically significant abnormality in laboratory examination tests
Incidence of clinically significant abnormality in blood routine, blood biochemistry,coagulation function and urine routine test results within 3 days after vaccination
Time frame: 0-3days after vaccination
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One dose of 0.5 mL placebo is aluminum phosphate adjuvant (aluminum content 0.25mg/dose), sodium chloride, succinic acid, polysorbate 80, and water for injection except for antigen components in 24-valent pneumococcal polysaccharide conjugate vaccine