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

GC Biopharma

Status and phase

Begins enrollment this month

Phase 3

Conditions

Chickenpox Vaccine

Varicella (Chickenpox)

Treatments

Biological: VARIVAX™

Biological: MG1111 (Barycela inj.)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07054099

MG1111_VAR2D_P0304

Details and patient eligibility

About

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.

Enrollment

474 estimated patients

Sex

All

Ages

12 months to 12 years old

Volunteers

Accepts Healthy Volunteers

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