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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 1200 participants(including 600 subjects aged 2~17 years,240 subjects aged 18~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd |
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| Control Group | Active Comparator | 600 participants(including 300 subjects aged 2~17 years,120 subjects aged 18~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp & Dohme. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 23-valent PPV | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after vaccination |
| Immunogenicity index-Geometric Mean Increase (GMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weijun Hu | Shanxi Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linwei District Center for Disease Control and Prevention | Weinan | Shanxi | 710000 | China |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Control 23-valent PPV | Biological | 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. |
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Geometric Mean Increase (GMI) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination. |
| 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. | 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. | 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. | 30 days after vaccination |
| Safety index-Incidence of adverse reactions | Incidence of adverse reactions within 30 days after vaccination. | Within 30 days after vaccination |
| Safety index-incidence of adverse reactions | Incidence of adverse reactions within 7 days after vaccination | Within 7 days after vaccination |
| Safety index-Incidence of serious adverse events | Incidence of serious adverse events within 30 days after vaccination. | Within 30 days after vaccination |
| D007239 | Infections |