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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361866
• Other study ID #: GC1107_AD_P3
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2014
• Last updated: February 11, 2015
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Randomized, double blind, multicenter, phaseⅢ study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Biological:
• GC1107
0.5 ml, Intramuscular, single dose(day0)
• Tetanus and Diphtheria(Td vaccine)
0.5ml, Intramuscular, single dose(day0) only applicable step1

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's Hospital Catholic Univ.	Incheon	Bupyeong 6-dong, Bupyeong-gu,

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroprotection rate of diphtheria and tetanus		28days	No
Secondary	GMT (Geometric Mean Titer)		28days	No
Secondary	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	No
Secondary	solicited adverse events		7days	No
Secondary	unsolicited adverse events		28 days	No
Secondary	Seroprotection rate according to the respective age group		28days	No
Secondary	GMT according to the respective age group		28days	No