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The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBVE013 | Experimental | 13-valent pneumococcal conjugate vaccine |
|
| LBVE014 | Experimental | 14-valent pneumococcal conjugate vaccine |
|
| Prevnar13 | Active Comparator | 13-valent pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal conjugate vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited adverse events | Baseline(pre-vaccination) up to 7 days after vaccination | |
| Unsolicited adverse events | Baseline(pre-vaccination) up to 4 weeks after vaccination | |
| Immediate reactions after vaccination | Baseline(pre-vaccination) up to 30 minutes after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination | 4 weeks after vaccination | |
| Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myoung-don Oh, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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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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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| 4 weeks after vaccination |
| Serotype-Specific Pneumococcal IgG antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination | 4 weeks after vaccination |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |