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

January 23, 2024 updated by: Green Cross Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of fever (temperature ≥39.0℃)
Time Frame: within 7 days
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
within 7 days
Solicited local / systemic adverse events
Time Frame: within 7 days
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
within 7 days
Unsolicited adverse events
Time Frame: within 42 days
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)
Time Frame: within 42 days
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℃)
Time Frame: within 42days
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)
Time Frame: within 42 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious adverse events
Time Frame: within 1 year
Serious adverse events that occurred within 1 year after the IP administration
within 1 year
GMT and GMR of the antibody titer
Time Frame: at Day1, Day42
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GMV and GMR of VZV-CMI response
Time Frame: at Day1, Day42
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
Time Frame: at Year1, Year2, Year3
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
Time Frame: anytime within 3 years (if applicable)
Varicella-like rash occurred after IP administration for 3 years
anytime within 3 years (if applicable)
Varicella-zoster virus genotyping
Time Frame: anytime within 3 years (if applicable)
Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
anytime within 3 years (if applicable)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Green Cross Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yun-kyung Kim, M.D., Ph.D, Korea University Ansan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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