This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.
This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day 0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,800
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for 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 in 0.5 mL of sodium chloride mixture per injection.
The First People's Hospital of Yuanping Medical Group
Yuanping, Shanxi, China
Salt Lake District Center for Disease Control and Prevention
Yuncheng, Shanxi, China
Immunogenicity index-Geometric Mean Concentration (GMC)
GMC for serotype-specific pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-Geometric Mean Increase (GMI)
GMI for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Seroconversion rate (2-fold increase rate) for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination
Time frame: Within 30 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Time frame: Within 7 days after vaccination
Safety index-Incidence of serious adverse events
Incidence of serious adverse events within 30 days after vaccination.
Time frame: Within 30 days after vaccination
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