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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813486
Recruitment Status : Unknown
Verified November 2016 by Green Cross Corporation.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : November 6, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date November 6, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • 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) ]
  • Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens [ Time Frame: 28 days after Vaccination ]
  • Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens [ Time Frame: 28 days after Vaccination ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine [ Time Frame: Up to 30 minutes post-vaccination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
Official Title  ICMJE Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Tetanus
  • Diphtheria
  • Whooping Cough
Intervention  ICMJE
  • Biological: Biological: GC3111 vaccine
    0.5mL, Intramuscular
    Other Name: GC3111
  • Biological: Biological: Boostrix® vaccine
    0.5mL, Intramuscular
    Other Name: Boostrix®
Study Arms  ICMJE
  • Experimental: GC3111 Vaccine Group
    Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
    Intervention: Biological: Biological: GC3111 vaccine
  • Active Comparator: Boostrix® Vaccine Group
    Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
    Intervention: Biological: Biological: Boostrix® vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 22, 2016)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813486
Other Study ID Numbers  ICMJE GC3111_P1/2a
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Green Cross Corporation
Study Sponsor  ICMJE Green Cross Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Green Cross Corporation
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP