A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults
Primary Purpose
Tetanus, Diphtheria, Whooping Cough
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC3111 vaccine
Boostrix® vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus
Eligibility Criteria
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
Sites / Locations
- The Catholic Univ. of Korea Eunpyeong St. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GC3111 Vaccine Group
Boostrix® Vaccine Group
Arm Description
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
Outcomes
Primary Outcome Measures
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Vital Signs
Blood Pressure (systolic, diastolic) in mmHg
Vital Signs
Pulse Rate in pulses per minute
Vital Signs
Body Temperature in degrees Celcius
Laboratory Examinations
Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count
Laboratory Examinations
Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)
Laboratory Examinations
Urine Test (pH, specific gravity, bilirubin etc.)
Secondary Outcome Measures
Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens
Full Information
NCT ID
NCT04238975
First Posted
January 8, 2020
Last Updated
January 20, 2020
Sponsor
Green Cross Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04238975
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Whooping Cough
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
213 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GC3111 Vaccine Group
Arm Type
Experimental
Arm Description
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Arm Title
Boostrix® Vaccine Group
Arm Type
Active Comparator
Arm Description
Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
Intervention Type
Biological
Intervention Name(s)
GC3111 vaccine
Other Intervention Name(s)
GC3111
Intervention Description
0.5mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Boostrix® vaccine
Other Intervention Name(s)
Boostrix®
Intervention Description
0.5mL, Intramuscular
Primary Outcome Measure Information:
Title
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Time Frame
Day 0 (pre-vaccination) to Day 14 (post-vaccination)
Title
Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Time Frame
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Title
Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Time Frame
Day 0 (pre-vaccination) to Day 180 (post-vaccination)
Title
Vital Signs
Description
Blood Pressure (systolic, diastolic) in mmHg
Time Frame
Day 0 (pre-vaccination), Day 28 (post-vaccination)
Title
Vital Signs
Description
Pulse Rate in pulses per minute
Time Frame
Day 0 (pre-vaccination), Day 28 (post-vaccination)
Title
Vital Signs
Description
Body Temperature in degrees Celcius
Time Frame
Day 0 (pre-vaccination), Day 28 (post-vaccination)
Title
Laboratory Examinations
Description
Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count
Time Frame
Screening (pre-vaccination), Day 28 (post-vaccination)
Title
Laboratory Examinations
Description
Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)
Time Frame
Screening (pre-vaccination), Day 28 (post-vaccination)
Title
Laboratory Examinations
Description
Urine Test (pH, specific gravity, bilirubin etc.)
Time Frame
Screening (pre-vaccination), Day 28 (post-vaccination)
Secondary Outcome Measure Information:
Title
Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time Frame
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Title
Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time Frame
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Title
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time Frame
Day 28 (post-vaccination)
Title
Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time Frame
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Other Pre-specified Outcome Measures:
Title
Functional Antibody Response of Pertussis
Time Frame
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Title
Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative)
Time Frame
Day 0 (pre-vaccination), Day 28 (post-vaccination)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dah Yoon Kim
Phone
+82-31-260-0976
Email
kimdahyoon@greencross.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sujin Lee
Phone
+82-31-260-0870
Facility Information:
Facility Name
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults
We'll reach out to this number within 24 hrs