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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
474
MG1111 (Barycela inj.)
Varivax™
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, Thailand
RECRUITINGProportion of participants who achieved seroconversion at 42 days after second vaccination
Time frame: 42 days after second vaccination
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
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
Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX
Time frame: 6 months after second vaccination
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