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The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety 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 |
|---|---|---|---|---|
| GC3111 vaccine | Biological | 0.5mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine | Day 0 (pre-vaccination) to Day 14 (post-vaccination) | |
| Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | |
| Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine | Day 0 (pre-vaccination) to Day 180 (post-vaccination) | |
| Vital Signs | Blood Pressure (systolic, diastolic) in mmHg | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Vital Signs | Pulse Rate in pulses per minute | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Vital Signs | Body Temperature in degrees Celcius | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Laboratory Examinations | Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count | Screening (pre-vaccination), Day 28 (post-vaccination) |
| Laboratory Examinations | Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.) | Screening (pre-vaccination), Day 28 (post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | |
| Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Antibody Response of Pertussis | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | |
| Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative) | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dah Yoon Kim | Contact | +82-31-260-0976 | kimdahyoon@greencross.com | |
| Sujin Lee | Contact | +82-31-260-0870 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| 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 |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
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| Boostrix® vaccine | Biological | 0.5mL, Intramuscular |
|
|
| Laboratory Examinations | Urine Test (pH, specific gravity, bilirubin etc.) | Screening (pre-vaccination), Day 28 (post-vaccination) |
| Day 0 (pre-vaccination) to Day 28 (post-vaccination) |
| Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens | Day 28 (post-vaccination) |
| Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens | Day 0 (pre-vaccination) to Day 28 (post-vaccination) |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |