Diphtheria, Tetanus, Whooping Cough
Conditions
Brief summary
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.
Detailed description
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults. To evaluate safety of GC3111 in healthy adults.
Interventions
BIOLOGICALGC3111 vaccine
0.5mL, Intramuscular
BIOLOGICALBoostrix® vaccine
0.5mL, Intramuscular
Sponsors
Green Cross Corporation
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
1. Healthy adults aged above 19 and under 64 at the time of screening 2. Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug 3. Subject who provided informed consent and assent forms
Exclusion criteria
1. Subject who received vaccine within 4 weeks prior to receiving study vaccine 2. Subject who received Tdap vaccine prior to receiving study vaccine 3. Subject with chronic cough history within 12 weeks before receiving study vaccine 4. Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence 5. Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine 6. Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Blood Pressure (systolic, diastolic) in mmHg |
| 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) | — |
| Laboratory Examinations | Screening (pre-vaccination), Day 28 (post-vaccination) | Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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 | Day 0 (pre-vaccination) to Day 28 (post-vaccination) |
| Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens | Day 28 (post-vaccination) |
Other
| Measure | 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) |
Countries
South Korea
Contacts
Primary ContactDah Yoon Kim
Backup ContactSujin Lee
Outcome results
None listed