A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years

NCT ID: NCT07054099

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2036-07-31

Brief Summary

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This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.

Detailed Description

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Conditions

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Varicella (Chickenpox) Chickenpox Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MG1111 (Barycela inj.)

Group Type EXPERIMENTAL

MG1111 (Barycela inj.)

Intervention Type BIOLOGICAL

MG1111 (Barycela inj.)

Varivax™

Group Type ACTIVE_COMPARATOR

VARIVAX™

Intervention Type BIOLOGICAL

Varivax™

Interventions

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MG1111 (Barycela inj.)

MG1111 (Barycela inj.)

Intervention Type BIOLOGICAL

VARIVAX™

Varivax™

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent.
* Participant is overtly healthy as determined by the investigator

Exclusion Criteria

* Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening
* Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV
* Participants with acute moderate or severe infection with or without fever at the time of dosing
* Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product
Minimum Eligible Age

12 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GC Biopharma Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Minji Ko

Role: CONTACT

+82-31-260-9143

Sujin Lee

Role: CONTACT

Other Identifiers

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MG1111_VAR2D_P0304

Identifier Type: -

Identifier Source: org_study_id

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