A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults
Phase 2
- Conditions
- DiphtheriaWhooping CoughTetanus
- Interventions
- Biological: Boostrix® vaccineBiological: GC3111 vaccine
- Registration Number
- NCT04238975
- Lead Sponsor
- Green Cross Corporation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 213
Inclusion Criteria
- Healthy adults aged above 19 and under 64 at the time of screening
- Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
- Subject who provided informed consent and assent forms
Exclusion Criteria
- Subject who received vaccine within 4 weeks prior to receiving study vaccine
- Subject who received Tdap vaccine prior to receiving study vaccine
- Subject with chronic cough history within 12 weeks before receiving study vaccine
- Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
- Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Boostrix® Vaccine Group Boostrix® vaccine Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine). GC3111 Vaccine Group GC3111 vaccine Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
- Primary Outcome Measures
Name Time Method 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 Day 0 (pre-vaccination), Day 28 (post-vaccination) Body Temperature in degrees Celcius
Laboratory Examinations Screening (pre-vaccination), Day 28 (post-vaccination) Urine Test (pH, specific gravity, bilirubin etc.)
- Secondary Outcome Measures
Name Time Method 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) 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) 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)
Trial Locations
- Locations (1)
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of