Overview
- 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
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 2. 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
3. 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
Eligibility
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