Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG1111 (Barycela inj.) | Experimental |
| |
| Varivax™ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG1111 (Barycela inj.) | Biological | MG1111 (Barycela inj.) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieved seroconversion at 42 days after second vaccination | 42 days after second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX | 7 days after each vaccination | |
| Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minji Ko | Contact | +82-31-260-9143 | mg1111d@gccorp.com | |
| Sujin Lee | Contact | mg1111d@gccorp.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Srinagarind Hospital | Recruiting | Khon Kaen | Changwat Khon Kaen | 40002 | Thailand |
Not provided
Not provided
Not provided
Not provided
Not provided
| VARIVAX™ |
| Biological |
Varivax™ |
|
| 42 days after each vaccination |
| Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX | 6 months after second vaccination |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided