Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

Green Cross Corporation

Status and phase: Enrolling; Phase 2

Conditions: Varicella

Treatments: Biological: VARIVAX; Biological: MG1111 (BARICELA); Biological: Suduvax

Study type: Interventional

Funder types: Industry

Identifiers

NCT05422508

MG1111_VAR_P0201

Details and patient eligibility

About

• Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination
• Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination

Full description

Safety

Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration Solicited local/systemic AEs occurred within 7 days after the IP administration Unsolicited adverse events that occurred within 42 days after the IP administration Serious adverse events that occurred within 1 year after the IP administration Vital signs and physical examinations

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

GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years

Enrollment: 230 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children between 4 and 6 years of age as of the date of written consent
• Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
• Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
• Negative history of Varicella infection

Exclusion criteria

• Subjects with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before the administration of investigational drug
• Subjects who have a history 2 times or more of varicella vaccine injections
• Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
• Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
• Subjects with a history of Guillain-Barre syndrome.
• Subjects with a severe chronic disease and considered ineligible for the study at Investigator's discretion
• Subjects with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin)
• Active tuberculosis patient
• Subjects who had received other vaccinations within 4 weeks before the administration of investigational product
• Subjects with immunodeficiency history
• Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug
• Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug
• Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before the administration of investigational drug
• A. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.
• B. Subjects who administered high dose of corticosteroids (greater than 2 mg/kg/day in case of under 10kg subjects or ≥20mg/day in case of above 10kg subject of prednisone for 14 days) (However, inhaled, intranasal, topical corticosteroids administration in allowed)
• Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug
• Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product
• Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 3 patient groups

MG1111(BARICELA) arm

Experimental group

Description:

0.5ml, single dose, subcutaneous injection

Treatment:

Biological: MG1111 (BARICELA)

VARIVAX arm

Active Comparator group

Description:

0.5ml, single dose, subcutaneous injection

Treatment:

Biological: VARIVAX

Suduvax arm

Active Comparator group

Description:

0.5ml, single dose, subcutaneous injection

Treatment:

Biological: Suduvax