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The purpose of this study is to determine whether varicella live vaccine is safe and effective in the healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG1111 | Experimental |
| |
| VARIVAX | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG1111 | Biological | Low, Medium, High Plaque-Forming Unit (PFU) of MG1111 in 0.5 mL dose is administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the solicited adverse events and unsolicited adverse events during 7 days after vaccination | 7 days | |
| To evaluate the unsolicited adverse events during 42 days after vaccination | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using FAMA assay antibody titer at Day 42 | 42 days | |
| To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using gpELISA antibody titer at Day 42 | 42 days |
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Inclusion Criteria:
Healthy male and female individuals between 20 and 55 years of age at screening test
If male who is sexually active with the female "of childbearing potential" , the individuals who agree to use any of the acceptable contraceptive methods during this study period and agree to not donate the sperm until 1 month
At screening visits, individuals who are over 55 kg in man, over 50kg in woman and whose ideal body weight is within 20 % ((ideal body weight = (height -100)*0.9)
Individual who has no clinically significant abnormalities in screening test within 28 days prior to vaccination
Individuals who were voluntarily signed informed consent form after receiving education about this study and able to comply with the requirements for the study
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| VARIVAX | Biological | VARIVAX is administered by subcutaneous injection |
|
| D007239 | Infections |
| D045424 |
| Complex Mixtures |