This is a cross-over, open-label, single-group study. The study subjects were children 12 months to 12 years of age who will be vaccinated with a single dose. The duration of follow-up for safety evaluation and immunogenicity (on a small group) is 6 weeks (+ 2 weeks). The main target: • Evaluating the safety of live attenuated Varicella vaccine \[Oka / SK\], lyophilized powder and solvent for subcutaneous injection (SKYVaricella inj.) in healthy Vietnamese children from 12 months to 12 years, with a single injection. Secondary target: • Assess the immunogenicity of live attenuated Varicella vaccine \[Oka / SK\], lyophilized powder and solvent for subcutaneous injection (SKYVaricella inj.) in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.
The Safety of Skyvaricella Injection: * The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated) between 1 and 6 weeks after vaccination * The incidence and severity of events (local and systemic) within 30 minutes after vaccination * The incidence of expected systemic and local adverse events within 7 days after vaccination * The incidence of serious adverse events and Unexpected adverse events within 6 weeks after vaccination The Immunogenicity of Skyvaricella Injection: seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test 6 weeks after investigational vaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
201
The main target is evaluating the safety of SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection. The secondary target is to Assess the immunogenicity of SKYVaricella inj. in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.
CDC Ha Nam
Phủ Lý, Ha Nam, Vietnam
the Safety of Skyvaricella Injection
The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated).
Time frame: between 1 and 6 weeks after vaccination
the Safety of Skyvaricella Injection
The incidence and severity of events (local and systemic)
Time frame: within 30 minutes after vaccination
the Safety of Skyvaricella Inj.
The incidence of expected systemic and local adverse events
Time frame: within 7 days after vaccination
the Safety of Skyvaricella Injection
The incidence of serious adverse events and Unexpected adverse events
Time frame: within 6 weeks after vaccination
the Immunogenicity of Skyvaricella Injection
seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test
Time frame: 6 weeks after investigational vaccination
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