To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children

Detailed Description
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Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study

Official Title
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Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

Conditions
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Bacterial Infections

Intervention / Treatment
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* Biological: GC1107
* Biological: TD_PUR INJ / SK Td vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC1107-T5.0<br>Dosage: 0.5ml | Biological: GC1107<br>* GC1107-T5.0: low dose, GC1107-T7.5: high dose<br>|
| Experimental: GC1107-T7.5<br>Dosage: 0.5ml | Biological: GC1107<br>* GC1107-T5.0: low dose, GC1107-T7.5: high dose<br>|
| Active Comparator: TD_PUR INJ /SK Td vaccine<br>The name: step 1(phase 2)-SK Td vaccine step 2(phase 3)-TD_PUR INJ Dosage: 0.5ml | Biological: TD_PUR INJ / SK Td vaccine<br>* step 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step I-the seroprotection rate of diphtheria and tetanus | Number of participants after vaccination as a measure of the effectiveness | 28 days | 
| Step II-to assess noninferior of diphtheria and tetanus |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| StepI-GMT of diphtheria and tetanus |  | 28 days | 
| Step I-safety assessment-solicited adverse event |  | 42 days | 
| Step II-GMT of diphtheria and tetanus |  | 28 days | 
| Step II-safety assessment-solicited adverse event |  | 28 days | 
| Step II- Boosting response of diphtheria and tetanus |  | 28 |