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This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should be naïve of Pneumococcal vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP606 | Experimental | Participants aged over 50 years are given a 0.5mL dose of 13-valent peumococcal conjugate vaccine administered on day 0. |
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| Prodiax-23 | Active Comparator | Participants aged over 50 years are given a 0.5mL dose of 23-valent pneumococcal polysaccharide vaccine administered on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP606 | Biological | 13-valent peumococcal conjugate vaccine(13vPnC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month(Day 28) After Vaccination 1 | For the comparison of OPA GMTs elicited by NBP606 relative to Prodiax-23, the 2-sided 95% CI on the geometric mean ratio(GMR) for each serotype is calculated. | One month after vaccination 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific immunoglobulin(IgG) Geometric Mean Concentration (GMC) 1 Month(Day 28) After Vaccination 1 | For the comparison of IgG GMC elicited by NBP606 relative to Prodiax-23, the 2-sided 95% CI on the geometric mean ratio(GMR) for each serotype is calculated. | One Month After Vaccination 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MYUNGDON OH, MD | Seoul National University Hospital | Study Chair |
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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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| Prodiax-23 |
| Biological |
23-valent peumococcal polysaccharide vaccine(23vPS) |
|
| D007239 | Infections |