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Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
Sponsor: Shanghai Reinovax Biologics Co.,LTD
Summary
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.
Official title: A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
992
Start Date
2024-04-20
Completion Date
2026-03
Last Updated
2025-12-17
Healthy Volunteers
Yes
Conditions
Interventions
Reinovax PCV24 formulation 1
One dose of Reinovax PCV24 formulation 1(0.5mL)
Reinovax PCV24 formulation 2
One dose of Reinovax PCV24 formulation 1(0.5mL)
Reinovax PCV24 formulation 3
One dose of Reinovax PCV24 formulation 1(0.5mL)
PPSV23
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.
Locations (2)
Pizhou Center for Disease Control and Prevention
Pizhou, Jiangsu, China
Xuzhou Center for Disease Control and Prevention
Xuzhou, Jiangsu, China