Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 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 (solicited adverse events) of GC3111 in healthy adults.

Official Title
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Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine

Conditions
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Tetanus, Diphtheria, Whooping Cough

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged between 19 and 64 years at the time of vaccination Informed consent and assent forms have been signed and dated Exclusion Criteria: Known or suspected receipt of any Tdap vaccine Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence Receipt of any vaccine within 30 days before receiving study vaccine 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: 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: 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 |
| --- | --- | --- |
| Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine |  | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | 
| Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens |  | 28 days after Vaccination | 
| Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens |  | 28 days after Vaccination | 
| Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis |  | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine |  | Up to 30 minutes post-vaccination |