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This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3111B | Experimental | Participants randomized to receive a single dose of GC3111B vaccine. |
|
| Boostrix® | Active Comparator | Participants randomized to receive a single dose of Boostrix® vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3111B | Biological | 0.5 mL, Intramuscular injection |
| |
| Boostrix® |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited adverse events occurring by day 14 after administration of the investigational product | 14 days after administration of the IP | |
| Unsolicited adverse events occurring by day 28 after administration of the investigational product | 28 days after administration of the IP | |
| Acute adverse events occurring within 30 minutes after administration of the investigational product | 30 minutes after administration of the IP | |
| Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product | 180 days after administration of the IP | |
| Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations | 28 days after administration of the IP |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product | 28 days after administration of the IP | |
| Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minji Ko | Contact | +82-31-260-9143 | minji.ko@gccorp.com | |
| Sujin Lee | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital | Recruiting | Seoul | 1021 | South Korea |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
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| Biological |
0.5 mL, Intramuscular injection |
|
Boosting response rate: 1) If less than 0.1 IU/ml before vaccination, it should be 0.4 IU/ml or higher after the vaccination, or 2) if not less than 0.1 IU/ml before vaccination, it should be 4 times or higher after the vaccination.
| 28 days after administration of the IP |
| Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product | 28 days after administration of the IP |