A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, Positive Controlled phase Ib/II clinical trial.
A phase Ib/II clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese adults aged ≥18years. The trial is a randomized, double-blind, positive controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Pneumovax® manufactured by MSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
385
One dose of Sinovac Low-dosage PCV24 (0.5mL)
One dose of Sinovac Middle-dosage PCV24(0.5mL)
One dose of Sinovac High-dosage PCV24(0.5mL)
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, China
Incidence of adverse reactions
Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination
Time frame: 0-30 days after vaccination
Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMT) (phase II)
OPA GMT 30 days after vaccination
Time frame: 30 days after vaccination
Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4-fold(phase II)
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination
Time frame: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(phase II)
IgG GMC 30 days after vaccination
Time frame: 30 days after vaccination
Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4-fold(phase II)
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
Time frame: 30 days after vaccination
Incidence of clinically significant abnormality in laboratory examination tests(phase Ib)
Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination
Time frame: 0-3 days after vaccination
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
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One dose of PPV23 manufactured by MSD
Time frame: 0-7 days after vaccination
Incidence of serious adverse reactions(SAE)
Incidence of SAE within 6 months after vaccination
Time frame: 0-6 months after vaccination
Pneumococcal serotype-specific OPA GMI(phase II)
OPA GMI 30 days after vaccination
Time frame: 30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(phase II)
IgG GMI 30 days after vaccination
Time frame: 30 days after vaccination