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

Primary Purpose

Varicella

Status

Recruiting

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

MG1111 (BARICELA)

VARIVAX

Suduvax

About this trial

This is an interventional other trial for Varicella

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts 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 SUDUVAX inj. 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

Sites / Locations

Korea University Ansan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

MG1111(BARICELA) arm

VARIVAX arm

Suduvax arm

Arm Description

0.5ml, single dose, subcutaneous injection

Outcomes

Primary Outcome Measures

Incidence of fever (temperature ≥39.0℃)

Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration

Solicited local / systemic adverse events

Solicited local / systemic adverse events that occurred within 7 days after the IP administration

Unsolicited adverse events

Unsolicited adverse events that occurred within 42 days after the IP administration

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.

Incidence of fever (temperature ≥39.0℃)

Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration

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.

Secondary Outcome Measures

Serious adverse events

Serious adverse events that occurred within 1 year after the IP administration

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

Full Information

NCT ID

NCT05422508

First Posted

May 24, 2022

Last Updated

October 12, 2022

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05422508

Brief Title

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

Official Title

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 SUDUVAX Inj. Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 5, 2022 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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 before and 42 days after the IP administration GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration GMT and GMR antibody titer measured by gpELISA assay before and after the IP administration for 3 years 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicella

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

501 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MG1111(BARICELA) arm

Arm Type

Experimental

Arm Description

0.5ml, single dose, subcutaneous injection

Arm Title

VARIVAX arm

Arm Type

Active Comparator

Arm Description

0.5ml, single dose, subcutaneous injection

Arm Title

Suduvax arm

Arm Type

Active Comparator

Arm Description

0.5ml, single dose, subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

MG1111 (BARICELA)

Intervention Description

0.5ml, single dose, subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

VARIVAX

Intervention Description

0.5ml, single dose, subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Suduvax

Intervention Description

0.5ml, single dose, subcutaneous injection

Primary Outcome Measure Information:

Title

Incidence of fever (temperature ≥39.0℃)

Description

Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration

Time Frame

within 7 days

Title

Solicited local / systemic adverse events

Description

Solicited local / systemic adverse events that occurred within 7 days after the IP administration

Time Frame

within 7 days

Title

Unsolicited adverse events

Description

Unsolicited adverse events that occurred within 42 days after the IP administration

Time Frame

within 42 days

Title

Vital signs (blood pressure, pulse rate, respiration rate and body temperature)

Description

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.

Time Frame

within 42 days

Title

Incidence of fever (temperature ≥39.0℃)

Description

Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration

Time Frame

within 42days

Title

Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin)

Description

Time Frame

within 42 days

Secondary Outcome Measure Information:

Title

Serious adverse events

Description

Serious adverse events that occurred within 1 year after the IP administration

Time Frame

within 1 year

Title

GMT and GMR of the antibody titer

Description

GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration

Time Frame

at Day1, Day42

Other Pre-specified Outcome Measures:

Title

GMV and GMR of VZV-CMI response

Description

GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration

Time Frame

at Day1, Day42

Title

GMT and GMR of the antibody titer

Description

GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year

Time Frame

at Year1, Year2, Year3

Title

Varicella-like rash

Description

Varicella-like rash occurred after IP administration for 3 years

Time Frame

anytime within 3 years (if applicable)

Title

Varicella-zoster virus genotyping

Description

Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years

Time Frame

anytime within 3 years (if applicable)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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 SUDUVAX inj. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Na Hyung Kim

Phone

+82-31-260-1943

nahyung.kim@gccorp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Korea University Ansan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Ansan Hospital

City

Ansan

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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