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

A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to 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

• 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

Study Overview

• Status: Recruiting
• Conditions: Varicella
• Intervention / Treatment: Biological: MG1111 (BARICELA); Biological: VARIVAX; Biological: Suduvax

Detailed Description

1. 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

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hye Won Shin; Phone Number: +82-31-260-9032; Email: hwshin27@gccorp.com

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Recruiting
    • Korea University Ansan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG1111(BARICELA) arm; 0.5ml, single dose, subcutaneous injection	Biological: MG1111 (BARICELA); 0.5ml, single dose, subcutaneous injection
Active Comparator: VARIVAX arm; 0.5ml, single dose, subcutaneous injection	Biological: VARIVAX; 0.5ml, single dose, subcutaneous injection
Active Comparator: Suduvax arm; 0.5ml, single dose, subcutaneous injection	Biological: Suduvax; 0.5ml, single dose, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	at Day1, Day42

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Yun-kyung Kim, M.D., Ph.D, Korea University Ansan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: MG1111_VAR_P0201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No