This is a randomized, double-blind, positive-controlled 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 immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.
This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp \& Dohme.A total of 1800 subjects including 900 subjects aged 2\~17 years,360 subjects aged 18\~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
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, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection.
The control vaccine was manufactured by Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride.
Linwei District Center for Disease Control and Prevention
Weinan, Shanxi, China
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-Geometric Mean Concentration (GMC)
Geometric Mean Concentration (GMC) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-Geometric Mean Increase (GMI)
Geometric Mean Increase (GMI) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-Seroconversion rate
Seroconversion rate for serotype specificity (1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F)of pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-GMC
Geometric Mean Concentration (GMC) for serotype specificity (1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F)of pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
Immunogenicity index-GMI
Geometric Mean Increase (GMI) for serotype specificity (1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F)of pneumococcal IgG antibody 30 days after vaccination.
Time frame: 30 days after vaccination
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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