A phase II clinical trial of a 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 study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.
Phase II clinical trial of the 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 study's objective is to evaluate the safety and immunogenicity 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. At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
992
One dose of Reinovax PCV24 formulation 1(0.5mL)
One dose of Reinovax PCV24 formulation 1(0.5mL)
One dose of Reinovax PCV24 formulation 1(0.5mL)
Pizhou Center for Disease Control and Prevention
Pizhou, Jiangsu, China
Xuzhou Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
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
Positive conversion rate of specific IgG antibodies by serotype
The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group.
Time frame: 0~30 days after vaccination
The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus
The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus in subjects 30 days after immunization in each group
Time frame: 0~30 days after vaccination
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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.