A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults

Tetanus Clinical Trial

Official title:

Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238975
• Other study ID #: GC3111_P2
• Status: Recruiting
• Phase: Phase 2
• Start date: October 14, 2019
• Est. completion date: May 2021

Study information

• Verified date: January 2020
• Source: Green Cross Corporation
• Contact: Dah Yoon Kim
• Phone: +82-31-260-0976
• Email: kimdahyoon[@]greencross.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: May 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Tetanus
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univ. of Korea Eunpyeong 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
Other	Functional Antibody Response of Pertussis		Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Other	Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative)		Day 0 (pre-vaccination), Day 28 (post-vaccination)
Primary	Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 14 (post-vaccination)
Primary	Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Primary	Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 180 (post-vaccination)
Primary	Vital Signs	Blood Pressure (systolic, diastolic) in mmHg	Day 0 (pre-vaccination), Day 28 (post-vaccination)
Primary	Vital Signs	Pulse Rate in pulses per minute	Day 0 (pre-vaccination), Day 28 (post-vaccination)
Primary	Vital Signs	Body Temperature in degrees Celcius	Day 0 (pre-vaccination), Day 28 (post-vaccination)
Primary	Laboratory Examinations	Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count	Screening (pre-vaccination), Day 28 (post-vaccination)
Primary	Laboratory Examinations	Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)	Screening (pre-vaccination), Day 28 (post-vaccination)
Primary	Laboratory Examinations	Urine Test (pH, specific gravity, bilirubin etc.)	Screening (pre-vaccination), Day 28 (post-vaccination)
Secondary	Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary	Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary	Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens		Day 28 (post-vaccination)
Secondary	Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens		Day 0 (pre-vaccination) to Day 28 (post-vaccination)