Brief Title
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults
Official Title
Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
Brief Summary
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single
dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
Detailed Description
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap)
vaccine in healthy adults.
To evaluate safety of GC3111 in healthy adults.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Secondary Outcome
Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Condition
Tetanus
Intervention
GC3111 vaccine
Study Arms / Comparison Groups
GC3111 Vaccine Group
Description: Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
213
Start Date
October 14, 2019
Completion Date
May 2021
Primary Completion Date
February 2021
Eligibility Criteria
Inclusion Criteria:
1. Healthy adults aged above 19 and under 64 at the time of screening
2. Subject without history of administrating vaccines including diphtheria, tetanus or
whooping cough antigens within 2 years prior to administration of investigational drug
3. Subject who provided informed consent and assent forms
Exclusion Criteria:
1. Subject who received vaccine within 4 weeks prior to receiving study vaccine
2. Subject who received Tdap vaccine prior to receiving study vaccine
3. Subject with chronic cough history within 12 weeks before receiving study vaccine
4. Subject who is pregnant, lactating, or of child bearing potential without using an
effective method of contraception or not practicing abstinence
5. Subject who participated in any other clinical study (investigational drug/equipment)
within 6 months before receiving study vaccine
6. Subject with any condition that, in the opinion of the Investigator, might interfere
with the ability to comply with trial procedures
Gender
All
Ages
19 Years - 64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, +82-31-260-0976, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04238975
Organization ID
GC3111_P2
Responsible Party
Sponsor
Study Sponsor
Green Cross Corporation
Study Sponsor
, ,
Verification Date
January 2020