Phase 2 Study to Assess the Safety and Immune Response of MG1111 BARICELA as a Second Varicella Vaccine in Healthy Children Aged 4 to 6 with Prior Varicella Vaccination

What this Trial Is About

Researchers are studying the safety and immune response of MG1111 BARICELA Inj. when used as a second varicella vaccination in healthy children aged 4 to 6 years who have previously received a first varicella vaccination. This Phase 2 clinical trial aims primarily to assess safety up to 42 days after vaccination and secondarily to evaluate immune responses and ongoing safety. The study is designed as a double-blind, randomized, multi-center trial comparing MG1111 with two other varicella vaccines, VARIVAX and Suduvax. Participants receive a single 0.5ml dose of their assigned vaccine by subcutaneous injection as the second varicella vaccination. The trial includes three groups MG1111, VARIVAX, and Suduvax arms, each receiving the same dose and method of administration. The study monitors participants closely for safety and immune response over multiple time points, including an initial 42-day period and extended monitoring for up to three years for immune markers and varicella-related events. During the study, children will be monitored for fever, local and systemic side effects, physical exams, and vital signs within 42 days post-vaccination. Serious adverse events are tracked for up to one year. Blood samples will be taken to assess antibody levels and cellular immune responses before vaccination and at 42 days post-vaccination, with additional antibody testing up to three years. Researchers also evaluate any varicella-like rash and virus genetics during the extended follow-up. Participation involves regular visits for assessments and safety monitoring throughout the study duration.

Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination