Clinical trial NCT02813486: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Tetanus
Diphtheria
Whooping Cough
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
measure: Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
timeFrame: 28 days after Vaccination
measure: Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
timeFrame: 28 days after Vaccination
measure: Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis
timeFrame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary outcomes:
measure: Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine
timeFrame: Up to 30 minutes post-vaccination
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital Catholic Univ.
state: Bupyeong 6-dong, Bupyeong-gu,
city: Daejeon
country: Korea, Republic of
facility: The Catholic Univ. of Korea Daejeon St.Mary's Hospital
state: Jung-Gu
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ.of Korea Bucheon St.Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Study officials:
References: