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The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Single dose of EuTCV will be administered intramuscularly |
|
| Comparator group 1 | Active Comparator | Single dose of Typbar-TCV™ will be administered intramuscularly |
|
| Comparator group 2 | Active Comparator | Single dose of Typhim Vi® will be administered intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuTCV | Biological | Single 0.5 mL dose of TCV of EuBiologics co., Ltd. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic solicited adverse events | Day 7 | |
| Unsolicited adverse events | up to 6 weeks | |
| Serious adverse events | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with seroconversion | Defined as a 4-fold or more rise in anti-Vi antibody titers | Baseline to Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De La Salle Health Sciences Institute | Dasmariñas | Cavite | 4114 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33849723 | Derived | Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, Lee C. An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021 May 6;39(19):2620-2627. doi: 10.1016/j.vaccine.2021.03.089. Epub 2021 Apr 10. |
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| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C057664 | Vi polysaccharide vaccine, typhoid |
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Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
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| Typbar-TCV™ |
| Biological |
Single 0.5 mL dose of TCV of Bharat Biotech |
|
| Typhim Vi® | Biological | Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |