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

Last updated: July 10, 2025
Sponsor: GC Biopharma Corp
Overall Status: Active - Not Recruiting

Phase

3

Condition

Rash

Shingles

Treatment

MG1111 (Barycela inj.)

VARIVAX™

Clinical Study ID

NCT07054099
MG1111_VAR2D_P0304
  • Ages 12-12
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 12 months to 12 years of age, inclusive, at the time of signingthe informed consent or assent.

  • Participant is overtly healthy as determined by the investigator

Exclusion

Exclusion Criteria:

  • Participants with a history of exposure to varicella through contact with avaricella patient at home, school, or childcare facility within 4 weeks beforeScreening

  • Participants with a history of varicella infection and varicella vaccine, eitherlicensed or investigational, and either standalone or any combination, such as MMRV

  • Participants with acute moderate or severe infection with or without fever at thetime of dosing

  • Participants who have had any suspected allergy symptoms, such as systemic rash,during the 72 hours before each administration of investigational product

Study Design

Total Participants: 474
Treatment Group(s): 2
Primary Treatment: MG1111 (Barycela inj.)
Phase: 3
Study Start date:
March 01, 2026
Estimated Completion Date:
July 31, 2036