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

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

Detailed Description
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Randomized, double blind, multicenter, phaseⅢ study

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

Conditions
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Bacterial Infections

Intervention / Treatment
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* Biological: GC1107
* Biological: Tetanus and Diphtheria(Td vaccine)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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<br>0.5ml, intramuscular, a single dosing | Biological: GC1107<br>* 0.5 ml, Intramuscular, single dose(day0)<br>|
| Active Comparator: Tetanus and Diphtheria(Td vaccine)<br>0.5ml, intramuscular, a single dosing | Biological: Tetanus and Diphtheria(Td vaccine)<br>* 0.5ml, Intramuscular, single dose(day0) only applicable step1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprotection rate of diphtheria and tetanus |  | 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT (Geometric Mean Titer) |  | 28days | 
| 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 | 
| solicited adverse events |  | 7days | 
| unsolicited adverse events |  | 28 days | 
| Seroprotection rate according to the respective age group |  | 28days | 
| GMT according to the respective age group |  | 28days |