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

NCT04238975 | Unknown Phase 2

• 1 other identifier: GC3111_P2
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetanus; Diphtheria; Whooping Cough

Outcome Measures

Primary Outcomes (9)

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

  Day 0 (pre-vaccination) to Day 14 (post-vaccination)

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

  Day 0 (pre-vaccination) to Day 28 (post-vaccination)

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

  Day 0 (pre-vaccination) to Day 180 (post-vaccination)

• Vital Signs

  Blood Pressure (systolic, diastolic) in mmHg

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Vital Signs

  Pulse Rate in pulses per minute

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Vital Signs

  Body Temperature in degrees Celcius

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

• Laboratory Examinations

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

  Screening (pre-vaccination), Day 28 (post-vaccination)

• Laboratory Examinations

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

  Screening (pre-vaccination), Day 28 (post-vaccination)

• Laboratory Examinations

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

  Screening (pre-vaccination), Day 28 (post-vaccination)

Secondary Outcomes (4)

• 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)

• 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)

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

  Day 28 (post-vaccination)

• 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)

Other Outcomes (2)

• Functional Antibody Response of Pertussis

  Day 0 (pre-vaccination) to Day 28 (post-vaccination)

• Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative)

  Day 0 (pre-vaccination), Day 28 (post-vaccination)

Study Arms (2)

GC3111 Vaccine Group

EXPERIMENTAL

Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).

Biological: GC3111 vaccine

Boostrix® Vaccine Group

ACTIVE COMPARATOR

Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).

Biological: Boostrix® vaccine

Interventions

GC3111 vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: GC3111

GC3111 Vaccine Group

Boostrix® vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: Boostrix®

Boostrix® Vaccine Group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged above 19 and under 64 at the time of screening
• Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
• Subject who provided informed consent and assent forms

You may not qualify if:

• Subject who received vaccine within 4 weeks prior to receiving study vaccine
• Subject who received Tdap vaccine prior to receiving study vaccine
• Subject with chronic cough history within 12 weeks before receiving study vaccine
• Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
• Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
• Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Tetanus; Diphtheria; Whooping Cough

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

Dah Yoon Kim

CONTACT

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

Sujin Lee

CONTACT

+82-31-260-0870

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 23, 2020
• Study Start: October 14, 2019
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)