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The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.
Randomized, double blind, multicenter, phaseâ…¢ study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC1107 | Experimental | 0.5ml, intramuscular, a single dosing |
|
| Tetanus and Diphtheria(Td vaccine) | Active Comparator | 0.5ml, intramuscular, a single dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC1107 | Biological | 0.5 ml, Intramuscular, single dose(day0) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| seroprotection rate of diphtheria and tetanus | 28days |
| Measure | Description | Time Frame |
|---|---|---|
| GMT (Geometric Mean Titer) | 28days | |
| Boosting response of diphtheria and tetanus compared participants with before and after the injection | Boosting response is defined as more 4 times increase of the antibody titer after the injection |
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Inclusion Criteria:
Exclusion Criteria:
subjects who have already got the additional vaccination of Td within 5 years
subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)
subjects who have not recovered from the acute disease within 2 weeks
subjects who have the medical history of allergic disease related to the components of investigational drug
who got the treatment of blood product and immunoglobulin product within 3 months
females who are pregnant
females who are breastfeeding
subjects who are infected from the diphtheria and tetanus
subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
Subjects who are scheduled to participate in other clinical trial studies during the study
Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
Those who take the other medicine that affects this study or are vaccinated other vaccines
Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
Subjects with a history of chronic disease obstacles to the study.
Subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study
Subject who have plan of operation during the study.
Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| JungHyeon Choi, MD | Incheon St. Mary's Hospital Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheon St. Mary's Hospital Catholic Univ. | Incheon | Bupyeong 6-dong, Bupyeong-gu, | 1544-9004 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30686952 | Derived | Lee J, Choi JH, Wie SH, Park SH, Choi SM, Lee MS, Kim TH, Lee HJ, Kang JH. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. J Korean Med Sci. 2019 Jan 16;34(4):e31. doi: 10.3346/jkms.2019.34.e31. eCollection 2019 Jan 28. |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Tetanus and Diphtheria(Td vaccine) |
| Biological |
0.5ml, Intramuscular, single dose(day0) only applicable step1 |
|
| 28days |
| solicited adverse events | 7days |
| unsolicited adverse events | 28 days |
| Seroprotection rate according to the respective age group | 28days |
| GMT according to the respective age group | 28days |