Clinical trial NCT04238975: A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults
Official title: Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tetanus
Diphtheria
Whooping Cough
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 213
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
timeFrame: Day 0 (pre-vaccination) to Day 14 (post-vaccination)
measure: Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
measure: Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
timeFrame: Day 0 (pre-vaccination) to Day 180 (post-vaccination)
measure: Vital Signs
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Vital Signs
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Vital Signs
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
measure: Laboratory Examinations
timeFrame: Screening (pre-vaccination), Day 28 (post-vaccination)
measure: Laboratory Examinations
timeFrame: Screening (pre-vaccination), Day 28 (post-vaccination)
measure: Laboratory Examinations
timeFrame: Screening (pre-vaccination), Day 28 (post-vaccination)
Secondary outcomes:
measure: Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
measure: Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
measure: Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
timeFrame: Day 28 (post-vaccination)
measure: Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Other outcomes:
measure: Functional Antibody Response of Pertussis
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
measure: Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative)
timeFrame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Study officials:
References: