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Safety
Efficacy (Immunogenicity)
-GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration
Exploratory assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG1111(BARICELA) arm | Experimental | 0.5ml, single dose, subcutaneous injection |
|
| VARIVAX arm | Active Comparator | 0.5ml, single dose, subcutaneous injection |
|
| Suduvax arm | Active Comparator | 0.5ml, single dose, subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG1111 (BARICELA) | Biological | 0.5ml, single dose, subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of fever (temperature ≥39.0℃) | Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration | within 7 days |
| Solicited local / systemic adverse events | Solicited local / systemic adverse events that occurred within 7 days after the IP administration | within 7 days |
| Unsolicited adverse events | Unsolicited adverse events that occurred within 42 days after the IP administration | within 42 days |
| Vital signs (blood pressure, pulse rate, respiration rate and body temperature) | descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) of change from baseline to 42 days will be presented for each group. | within 42 days |
| Incidence of fever (temperature ≥39.0℃) | Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration | within 42days |
| Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin) | the change from baseline to 42 days will be classified into 'normal/abnormal, not clinically significant (NCS)' or 'abnormal, clinically significant (CS)', and the frequency and percentage are presented in a shift table. | within 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Serious adverse events that occurred within 1 year after the IP administration | within 1 year |
| GMT and GMR of the antibody titer | GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| GMV and GMR of VZV-CMI response | GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration | at Day1, Day42 |
| GMT and GMR of the antibody titer | GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye Won Shin | Contact | +82-31-260-9032 | hwshin27@gccorp.com |
| Name | Affiliation | Role |
|---|---|---|
| Yun-kyung Kim, M.D., Ph.D | Korea University Ansan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | South Korea |
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After the Protocol v4.1 was approved by Ministry of Food and Drug Safety (02Jun2023), Subject eligibility was change to 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination instead of 1st SUDUVAX inj. and Active Comparator: VARIVAX arm was deleted.
*VARIVAX release has been discontinued.
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| VARIVAX |
| Biological |
0.5ml, single dose, subcutaneous injection |
|
| Suduvax | Biological | 0.5ml, single dose, subcutaneous injection |
|
| at Day1, Day42 |
| at Year1, Year2, Year3 |
| Varicella-like rash | Varicella-like rash occurred after IP administration for 3 years | anytime within 3 years (if applicable) |
| Varicella-zoster virus genotyping | Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years | anytime within 3 years (if applicable) |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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