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

Phase 3

Completed

• Conditions: Bacterial Infections
• Interventions: Biological: Tetanus and Diphtheria(Td vaccine); Biological: GC1107

• Registration Number: NCT02361866
• Lead Sponsor: Green Cross Corporation

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

Study Timeline

• Study First Submitted: 2014-04-22
• Study Start: 2014-05
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-11
• Last Update Submitted: 2015-02-11
• Study First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tetanus and Diphtheria(Td vaccine)	Tetanus and Diphtheria(Td vaccine)	0.5ml, intramuscular, a single dosing
GC1107	GC1107	0.5ml, intramuscular, a single dosing

Primary Outcome Measures

Name	Time	Method
seroprotection rate of diphtheria and tetanus	28days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Incheon St. Mary's Hospital Catholic Univ.; 🇰🇷 Incheon, Bupyeong 6-dong, Bupyeong-gu,, Korea, Republic of