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The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Primary objective:
To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR-TD-1001 | Experimental | Randomized subjects were assigned to receive a single dose of BR-TD-1001 |
|
| Td-pur inj | Active Comparator | Randomized subjects were assigned to receive a single dose of Td-pur inj |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR-TD-1001 | Biological | 0.5 mL, IM |
| |
| Td-pur inj |
| Measure | Description | Time Frame |
|---|---|---|
| The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products | Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA) | 28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products | 28 days after vaccination | |
| The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Hyun Kim | Saint Vincent's Hospital, Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changwon Fatima Hospital | Changwon | South Korea | ||||
| The Catholic University of Korea Daejeon St. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34931494 | Derived | Choi UY, Kim KH, Lee J, Eun BW, Kim HM, Lee KY, Kim DH, Ma SH, Lee J, Kim JH. Immunogenicity and Safety of a Newly Developed Tetanus-Diphtheria Toxoid (Td) in Healthy Korean Adolescents: a Multi-center, Randomized, Double-blind, Active-Controlled Phase 3 Trial. J Korean Med Sci. 2021 Dec 20;36(49):e313. doi: 10.3346/jkms.2021.36.e313. |
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double-blind
| Biological |
0.5 mL, IM |
|
| 28 days after vaccination |
| Daejeon |
| South Korea |
| The Catholic University of Korea Incheon St. Mary's Hospital | Incheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Eulji University Eulji General Hospital | Seoul | South Korea |
| Hanil General Hospital | Seoul | South Korea |
| Korea Cancer Center Hospital | Seoul | South Korea |
| The Catholic University of Korea St. Paul's Hospital | Seoul | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
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