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

Green Cross Corporation213 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

213

Conditions

Tetanus Diphtheria Whooping Cough

Interventions

GC3111 vaccineBIOLOGICAL

0.5mL, Intramuscular

Boostrix® vaccineBIOLOGICAL

0.5mL, Intramuscular

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine

Time frame: Day 0 (pre-vaccination) to Day 14 (post-vaccination)

Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine

Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine

Time frame: Day 0 (pre-vaccination) to Day 180 (post-vaccination)

Vital Signs

Blood Pressure (systolic, diastolic) in mmHg

Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)

Vital Signs

Pulse Rate in pulses per minute

Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)

Vital Signs

Body Temperature in degrees Celcius

Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)

Laboratory Examinations

Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count

Time frame: Screening (pre-vaccination), Day 28 (post-vaccination)

Laboratory Examinations

Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)

Time frame: Screening (pre-vaccination), Day 28 (post-vaccination)

Laboratory Examinations

Urine Test (pH, specific gravity, bilirubin etc.)

Central Contacts

Dah Yoon Kim

CONTACT

+82-31-260-0976 kimdahyoon@greencross.com

Sujin Lee

CONTACT

+82-31-260-0870

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine

Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine

Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens

Time frame: Day 28 (post-vaccination)

Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens

Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)