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

NCT ID: NCT02361866

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-10-31

Brief Summary

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

Detailed Description

Randomized, double blind, multicenter, phaseⅢ study

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GC1107

0.5ml, intramuscular, a single dosing

Group Type: EXPERIMENTAL

GC1107

Intervention Type: BIOLOGICAL

0.5 ml, Intramuscular, single dose(day0)

Tetanus and Diphtheria(Td vaccine)

0.5ml, intramuscular, a single dosing

Group Type: ACTIVE_COMPARATOR

Tetanus and Diphtheria(Td vaccine)

Intervention Type: BIOLOGICAL

0.5ml, Intramuscular, single dose(day0) only applicable step1

Interventions

GC1107

0.5 ml, Intramuscular, single dose(day0)

Intervention Type: BIOLOGICAL

Tetanus and Diphtheria(Td vaccine)

0.5ml, Intramuscular, single dose(day0) only applicable step1

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JungHyeon Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Incheon St. Mary's Hospital Catholic University

Locations

Incheon St. Mary's Hospital Catholic Univ.

Incheon, Bupyeong 6-dong, Bupyeong-gu,, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30686952 (View on PubMed)

Other Identifiers

GC1107_AD_P3

Identifier Type: -

Identifier Source: org_study_id