The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: * Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection) * Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection) Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
250
BARYCELA inj.
Safety of BARYCELA inj.: Solicited local and systemic reactogenicity
The incidence and severity of immediate solicited local and systemic reactogenicity
Time frame: within 30-minute post vaccination
Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs
The incidence and severity of solicited local and systemic AEs
Time frame: during 7 days post vaccination
Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs
The incidence and severity of unsolicited AEs
Time frame: during 42 days post vaccination
Safety of BARYCELA inj.: Incidence of adverse event of special interest
The incidence of AE of Special Interest (AESI): varicella-like rash.
Time frame: during 42 days post vaccination
Safety of BARYCELA inj.: Vital signs
Vital signs
Time frame: Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Body temperature
Body temperature; measured according to standard of care and thermometer instructions.
Time frame: Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Complete physical examination
Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42).
Time frame: Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Symptom-directed physical examination
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Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening
Time frame: Day0(Pre vaccination), during 42 days post vaccination
Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT)
Geometric Mean Titer (GMT) of antibody titer measured with gpELISA
Time frame: Prior to IP administration and 42 days post vaccination
Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR)
Geometric Mean Fold Rise (GMFR)
Time frame: Prior to IP administration and 42 days post vaccination