Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,200
lyophilized powder, subcutaneous injection
Huaiyin District Center for Disease Control and Prevention
Huaian, Jiangsu, China
seroconversion rate
The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies
Time frame: 42 days after completing the full course of vaccination.
geometric mean titer (GMT)
geometric mean titer (GMT) of VZV antibodies 42 days after vaccination
Time frame: 42 days after completing the full course of vaccination.
geometric mean fold increase (GMFI)
geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination
Time frame: 42 days after completing the full course of vaccination.
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