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

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02813486
• Other study ID #: GC3111_P1/2a
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 20, 2016
• Last updated: November 4, 2016
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Tetanus
• Whooping Cough

Intervention

Biological:
• Biological: GC3111 vaccine
0.5mL, Intramuscular
• Biological: Boostrix® vaccine
0.5mL, Intramuscular

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univ. of Korea Daejeon St.Mary's Hospital	Daejeon	Jung-Gu
Korea, Republic of	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	Incheon St. Mary's Hospital Catholic Univ.	Incheon	Bupyeong 6-dong, Bupyeong-gu,
Korea, Republic of	The Catholic Univ.of Korea Yeouido St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens		28 days after Vaccination	No
Primary	Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens		28 days after Vaccination	No
Primary	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)	No
Secondary	Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine		Up to 30 minutes post-vaccination	Yes