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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 7, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

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.

Condition or disease Intervention/treatment Phase
Tetanus Diphtheria Whooping Cough Biological: Biological: GC3111 vaccine Biological: Biological: Boostrix® vaccine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
Study Start Date : June 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: GC3111 Vaccine Group
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Biological: Biological: GC3111 vaccine
0.5mL, Intramuscular
Other Name: GC3111

Active Comparator: Boostrix® Vaccine Group
Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
Biological: Biological: Boostrix® vaccine
0.5mL, Intramuscular
Other Name: Boostrix®




Primary Outcome Measures :
  1. 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) ]
  2. Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens [ Time Frame: 28 days after Vaccination ]
  3. Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens [ Time Frame: 28 days after Vaccination ]
  4. 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 Measures :
  1. Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine [ Time Frame: Up to 30 minutes post-vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813486


Locations
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Korea, Republic of
Incheon St. Mary's Hospital Catholic Univ.
Incheon, Bupyeong 6-dong, Bupyeong-gu,, Korea, Republic of, 1544-9004
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
Daejeon, Jung-Gu, Korea, Republic of, 301-723
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
Gyeonggi-do, Korea, Republic of
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
Gyeonggi-do, Korea, Republic of
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02813486    
Other Study ID Numbers: GC3111_P1/2a
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Tetany
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs