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

NCT ID: NCT05422508

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2027-06-30

Brief Summary

• 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

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

Conditions

Varicella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

MG1111(BARICELA) arm

0.5ml, single dose, subcutaneous injection

Group Type: EXPERIMENTAL

MG1111 (BARICELA)

Intervention Type: BIOLOGICAL

0.5ml, single dose, subcutaneous injection

VARIVAX arm

0.5ml, single dose, subcutaneous injection

Group Type: ACTIVE_COMPARATOR

VARIVAX

Intervention Type: BIOLOGICAL

0.5ml, single dose, subcutaneous injection

Suduvax arm

0.5ml, single dose, subcutaneous injection

Group Type: ACTIVE_COMPARATOR

Suduvax

Intervention Type: BIOLOGICAL

0.5ml, single dose, subcutaneous injection

Interventions

MG1111 (BARICELA)

0.5ml, single dose, subcutaneous injection

Intervention Type: BIOLOGICAL

VARIVAX

0.5ml, single dose, subcutaneous injection

Intervention Type: BIOLOGICAL

Suduvax

0.5ml, single dose, subcutaneous injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun-kyung Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Korea University Ansan Hospital

Locations

Korea University Ansan Hospital

Ansan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hye Won Shin

Role: CONTACT

hwshin27@gccorp.com

+82-31-260-9032

Other Identifiers

MG1111_VAR_P0201

Identifier Type: -

Identifier Source: org_study_id