Tetanus-diphtheria-acellular Pertussis (Tdap)
Conditions
Brief summary
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.
Interventions
BIOLOGICALGC3111B
0.5 mL, Intramuscular injection
BIOLOGICALBoostrix®
0.5 mL, Intramuscular injection
Sponsors
GC Biopharma Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults aged 19 to 64 years old as of the date of written consent. * Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.
Exclusion criteria
* Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product. * Individuals with a history of Tdap vaccination prior to administration of the investigational product. * Pregnant and breastfeeding women. * Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations | 28 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 |
| Solicited adverse events occurring by day 14 after administration of the investigational product | 14 days after administration of the IP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product | 28 days after administration of the IP | 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. |
| 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 | — |
| Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product | 28 days after administration of the IP | — |
Countries
South Korea
Contacts
Primary ContactMinji Ko
Backup ContactSujin Lee
Outcome results
None listed