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The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety (solicited adverse events) of GC3111 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3111 Vaccine Group | Experimental | Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine). |
|
| Boostrix® Vaccine Group | Active Comparator | Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: GC3111 vaccine | Biological | 0.5mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | |
| Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens | 28 days after Vaccination | |
| Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens | 28 days after Vaccination | |
| Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis | Day 0 (pre-vaccination) to Day 28 (post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine | Up to 30 minutes post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheon St. Mary's Hospital Catholic Univ. | Incheon | Bupyeong 6-dong, Bupyeong-gu, | 1544-9004 | South Korea | ||
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| Biological: Boostrix® vaccine | Biological | 0.5mL, Intramuscular |
|
|
| The Catholic Univ. of Korea Daejeon St.Mary's Hospital |
| Daejeon |
| Jung-Gu |
| 301-723 |
| South Korea |
| The Catholic Univ.of Korea Bucheon St.Mary's Hospital | Gyeonggi-do | South Korea |
| The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital | Gyeonggi-do | South Korea |
| The Catholic Univ.of Korea Yeouido St.Mary's Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
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