To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Biological: GC1107; Biological: Tetanus and Diphtheria(Td vaccine)

Detailed Description

Randomized, double blind, multicenter, phaseⅢ study

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bupyeong 6-dong, Bupyeong-gu,
    • Incheon, Bupyeong 6-dong, Bupyeong-gu,, Korea, Republic of, 1544-9004
      • Incheon St. Mary's Hospital Catholic Univ.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy Korean adults (age: over 18 years)
• who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
• Subjects willing to provide written informed consent and able to comply with the requirements for the study

Exclusion Criteria:

• subjects who have already got the additional vaccination of Td within 5 years

• subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)

  • only applicable in step I
• subjects who have not recovered from the acute disease within 2 weeks
• subjects who have the medical history of allergic disease related to the components of investigational drug
• who got the treatment of blood product and immunoglobulin product within 3 months
• females who are pregnant
• females who are breastfeeding
• subjects who are infected from the diphtheria and tetanus
• subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
• Subjects who are scheduled to participate in other clinical trial studies during the study
• Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
• Those who take the other medicine that affects this study or are vaccinated other vaccines
• Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
• Subjects with a history of chronic disease obstacles to the study.
• Subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study
• Subject who have plan of operation during the study.
• Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC1107; 0.5ml, intramuscular, a single dosing	Biological: GC1107; 0.5 ml, Intramuscular, single dose(day0)
Active Comparator: Tetanus and Diphtheria(Td vaccine); 0.5ml, intramuscular, a single dosing	Biological: Tetanus and Diphtheria(Td vaccine); 0.5ml, Intramuscular, single dose(day0) only applicable step1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
seroprotection rate of diphtheria and tetanus	28days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT (Geometric Mean Titer)		28days
Boosting response of diphtheria and tetanus compared participants with before and after the injection	Boosting response is defined as more 4 times increase of the antibody titer after the injection	28days
solicited adverse events		7days
unsolicited adverse events		28 days
Seroprotection rate according to the respective age group		28days
GMT according to the respective age group		28days

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: JungHyeon Choi, MD, Incheon St. Mary's Hospital Catholic University

Publications and helpful links

General Publications

• Lee J, Choi JH, Wie SH, Park SH, Choi SM, Lee MS, Kim TH, Lee HJ, Kang JH. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. J Korean Med Sci. 2019 Jan 16;34(4):e31. doi: 10.3346/jkms.2019.34.e31. eCollection 2019 Jan 28.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: GC1107_AD_P3