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The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EuPCV15 | Experimental | Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. |
|
| Prevenar13 | Active Comparator | Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuPCV15 | Biological | 15-valent Pneumococcal conjugate vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Solicited AEs (Local and Systemic) | within 14 days after vaccination | |
| Incidence of Unsolicited AEs | within 28 days after vaccination | |
| Incidence of SAEs | within 180 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Seoul St.Mary's 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 |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| Prevenar13 |
| Biological |
13-valent Pneumococcal conjugate vaccine |
|
| D007239 | Infections |