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NCT Number: NCT07054099

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

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.

Recruiting

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Key information

Conditions

Varicella (Chickenpox) Chickenpox Chickenpox Vaccine DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MG1111 (Barycela inj.)

Biological

MG1111 (Barycela inj.)

VARIVAX™

Biological

Varivax™

Primary outcomes

  1. Proportion of participants who achieved seroconversion at 42 days after second vaccination

    Time frame: 42 days after second vaccination

Secondary outcomes

  1. Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX

    Time frame: 7 days after each vaccination

  2. Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX

    Time frame: 42 days after each vaccination

  3. Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX

    Time frame: 6 months after second vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Minji Ko

CONTACT

[email protected]

+82-31-260-9143

Sujin Lee

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

GC Biopharma Corp

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2036
First posted
Jul 8, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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