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To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG1111(Varicella vaccine) | Experimental | A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1 |
|
| Comparator(Varicella vaccine) | Active Comparator | A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Vaccine | Drug | The subject will receive investigational product or comparator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieved seroconversion | 42 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer(GMT) measured by the FAMA assay | At day 0 and Day 42 post-vaccination | |
| Geometric mean titer(GMT) measured by gpELISA | At day 0 and Day 42 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Local/systemic solicited AEs [Safety] | during the first 7 days after administration of IP | |
| Incidence of Unsolicited AEs [Safety] | Until Day 42 after administration of IP | |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The catholic university of Korea, Seoul st. mary's hospital | Banpo-dong | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Incidence of Serious adverse events [Safety] |
| Until 6 months after administration of IP |
| D045424 |
| Complex Mixtures |
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |