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This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously vaccinated with PCV13 (CanSino) |
| ||
| Previously vaccinated with PCV13 (Pfizer) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previously vaccinated with PCV13 (CanSino) | Other | 3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants | 4 years after completion of the full vaccination series | |
| Geometric mean concentration (GMC) of antibodies among trial participants | 4 years after completion of the full vaccination series |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants | 4 years after completion of the full vaccination series |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical study enrolled 100 participants from the 2-month-old (minimum 6 weeks) group who had previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who had completed blood sample collection at 1 and 2 years post-vaccination to assess immunogenicity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayi Huang | Contact | 022-58213600-6051 | jiayi.huang@cansinotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiqiang Xie | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
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| Previously vaccinated with PCV13 (Pfizer) | Other | 3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study. |
|
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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