Status:
COMPLETED
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
Lead Sponsor:
Green Cross Corporation
Conditions:
Bacterial Infections
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
Detailed Description
Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study
Eligibility Criteria
Inclusion
- healthy Korean children(age: 10 \~ 17)
- In the case of step1 (for step 1) 11\~12 years
- who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.)
- Subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian
Exclusion
- Subjects with antitoxin of diphtheria and tetanus ≥1.0IU/mL (ELISA)
- only applicable in step 1
- subjects who have not recovered from the acute disease within 2 weeks
- who has experienced the temporary platelet decrease or has the medical history of neurologic complication
- who has the medical history of allergic disease related to the components of investigational drug
- who has experienced the severe adverse events for the diphtheria and tetanus vaccination
- who got the vaccination of diphtheria and tetanus within 5 years
- who has not recovered from the acute disease within 2 weeks
- who got the treatment of blood product within 3 months
- who got the immunoglobulin should have the wash-out period
- who be infected from the diphtheria and tetanus
- Subjects who are scheduled to participate in other clinical trial studies during the study.
- Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine.
- Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
- 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 37.5) 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01402713
Start Date
August 1 2011
End Date
November 1 2013
Last Update
January 26 2015
Active Locations (1)
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1
The catholic university of Korea, Seoul st. mary's hospital
Banpo-dong, Seoul, South Korea