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The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are:
Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG1111 | Experimental | Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG1111 | Biological | BARYCELA inj. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of BARYCELA inj.: Solicited local and systemic reactogenicity | The incidence and severity of immediate solicited local and systemic reactogenicity | within 30-minute post vaccination |
| Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs | The incidence and severity of solicited local and systemic AEs | during 7 days post vaccination |
| Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs | The incidence and severity of unsolicited AEs | during 42 days post vaccination |
| Safety of BARYCELA inj.: Incidence of adverse event of special interest | The incidence of AE of Special Interest (AESI): varicella-like rash. | during 42 days post vaccination |
| Safety of BARYCELA inj.: Vital signs | Vital signs | Day0(Pre vaccination), 42 days post vaccination |
| Safety of BARYCELA inj.: Body temperature | Body temperature; measured according to standard of care and thermometer instructions. | Day0(Pre vaccination), 42 days post vaccination |
| Safety of BARYCELA inj.: Complete physical examination | Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42). | Day0(Pre vaccination), 42 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT) | Geometric Mean Titer (GMT) of antibody titer measured with gpELISA | Prior to IP administration and 42 days post vaccination |
| Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Safety of BARYCELA inj.: Symptom-directed physical examination | Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening | Day0(Pre vaccination), during 42 days post vaccination |
Geometric Mean Fold Rise (GMFR)
| Prior to IP administration and 42 days post vaccination |