Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and adults Aged 13-55 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,200
The vaccines require reconstitution with the provided sterile water for injection nd should be shaken well before use. Each human dose (0.5 ml) contains at least 3.3 log PFU of VZV.
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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