A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults

Study Overview
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Brief Summary
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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
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To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults. To evaluate safety of GC3111 in healthy adults.

Official Title
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Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults

Conditions
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Tetanus, Diphtheria, Whooping Cough

Intervention / Treatment
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* Biological: GC3111 vaccine
* Biological: Boostrix® vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC3111 Vaccine Group<br>Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine). | Biological: GC3111 vaccine<br>* 0.5mL, Intramuscular<br>* Other names: GC3111;|
| Active Comparator: Boostrix® Vaccine Group<br>Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine). | Biological: Boostrix® vaccine<br>* 0.5mL, Intramuscular<br>* Other names: Boostrix®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Blood Pressure (systolic, diastolic) in mmHg | Day 0 (pre-vaccination), Day 28 (post-vaccination) | 
| Vital Signs | Pulse Rate in pulses per minute | Day 0 (pre-vaccination), Day 28 (post-vaccination) | 
| Vital Signs | Body Temperature in degrees Celcius | Day 0 (pre-vaccination), Day 28 (post-vaccination) | 
| Laboratory Examinations | Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count | Screening (pre-vaccination), Day 28 (post-vaccination) | 
| Laboratory Examinations | Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.) | Screening (pre-vaccination), Day 28 (post-vaccination) | 
| Laboratory Examinations | Urine Test (pH, specific gravity, bilirubin etc.) | Screening (pre-vaccination), Day 28 (post-vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |