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

Primary Purpose

Tetanus, Diphtheria, Whooping Cough

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biological: GC3111 vaccine
Biological: Boostrix® vaccine
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Incheon St. Mary's Hospital Catholic Univ.
  • The Catholic Univ. of Korea Daejeon St.Mary's Hospital
  • The Catholic Univ.of Korea Bucheon St.Mary's Hospital
  • The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
  • The Catholic Univ.of Korea Yeouido St.Mary's Hospital

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

Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis

Secondary Outcome Measures

Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine

Full Information

First Posted
June 20, 2016
Last Updated
November 4, 2016
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02813486
Brief Title
Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
Official Title
Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (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)
Biological: GC3111 vaccine
Other Intervention Name(s)
GC3111
Intervention Description
0.5mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Biological: Boostrix® vaccine
Other Intervention Name(s)
Boostrix®
Intervention Description
0.5mL, Intramuscular
Primary Outcome Measure Information:
Title
Participants With Antibody Responses 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
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
Time Frame
28 days after Vaccination
Title
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time Frame
28 days after Vaccination
Title
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis
Time Frame
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary Outcome Measure Information:
Title
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time Frame
Up to 30 minutes 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 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.
Facility Information:
Facility Name
Incheon St. Mary's Hospital Catholic Univ.
City
Incheon
State/Province
Bupyeong 6-dong, Bupyeong-gu,
ZIP/Postal Code
1544-9004
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
City
Daejeon
State/Province
Jung-Gu
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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