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Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23
Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Summary
The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.
Official title: A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2023-01-30
Completion Date
2028-06-30
Last Updated
2024-04-04
Healthy Volunteers
Yes
Conditions
Interventions
23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)
All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm.
23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)
All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm.
23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)
All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm.
Locations (1)
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, China