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

A Phase III, Double-blind, Randomized, Multicenter, Multinational, Active-controlled, Non-inferiority 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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07054099

Enrollment

474

Registered

2025-07-08

Start date

2026-03-31

Completion date

2036-07-31

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella (Chickenpox), Chickenpox Vaccine

Brief summary

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.

Interventions

BIOLOGICALMG1111 (Barycela inj.)

MG1111 (Barycela inj.)

BIOLOGICALVARIVAX™

Varivax™

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Proportion of participants who achieved seroconversion at 42 days after second vaccination	42 days after second vaccination

Secondary

Measure	Time frame
Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX	7 days after each vaccination
Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX	42 days after each vaccination
Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX	6 months after second vaccination

Contacts

Primary ContactMinji Ko

minji.ko@gccorp.com+82-31-260-9143

Backup ContactSujin Lee

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026