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Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate vaccine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EuNmCV-5 | Experimental | Healthy adults received 0.5mL single intramuscular dose on Day 0. |
|
| Menveo | Active Comparator | Healthy adults received 0.5mL single intramuscular dose on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuNmCV-5 | Biological | 0.5mL single intramuscular dose on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse events | local and systemic AEs | within 7 days post vaccination |
| Occurrence of unsolicited adverse events | within 28 days post vaccination | |
| Occurrence of serious adverse events | within 180 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YJ Choi | EuBiologics Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39112515 | Derived | Kim Y, Bae S, Yu KS, Lee S, Lee C, Kim J, Her H, Oh J. A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine. NPJ Vaccines. 2024 Aug 7;9(1):140. doi: 10.1038/s41541-024-00935-8. |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D018074 | Vaccines, Conjugate |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Menveo | Biological | 0.5mL single intramuscular dose on Day 0 |
|
|
| D007239 | Infections |
| D000941 |
| Antigens |
| D001685 | Biological Factors |
| D001428 | Bacterial Vaccines |