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The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | 7-valent pneumococcal conjugate vaccine |
|
| Test Arm | Experimental | 13-valent pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-valent pneumococcal conjugate vaccine | Biological |
| ||
| 13-valent pneumococcal polysaccharide conjugate vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| positive rate after infant doses | the rate of the immunoglobulin G ≥0.35μg/ml after infant doses | 30 days after infant doses |
| GMC after infant doses | geometrical mean concentration of immunoglobulin G after infant doses | 30 days after infant doses |
| positive rate after booster dose | the rate of the immunoglobulin G ≥0.35μg/ml after booster dose | 30 days after booster dose |
| GMC after booster dose | geometrical mean concentration of immunoglobulin G after booster dose | 30 days after booster dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nianmin Shi | Beijing Chaoyang disease control and prevention center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27798013 | Derived | Chen JJ, Yuan L, Huang Z, Shi NM, Zhao YL, Xia SL, Li GH, Li RC, Li YP, Yang SY, Xia JL. Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China. BMJ Open. 2016 Oct 19;6(10):e012488. doi: 10.1136/bmjopen-2016-012488. |
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| Biological |
|
| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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