The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
5,997
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China
Biyang County Center for Disease Control and Prevention
Zhumadian, Henan, China
The incidences of varicella of each group
The first 30 cases of varicella occurred 30 days after injection will be collected.
Time frame: ≥30 cases reported 30 days after injection
The protection rate of the vaccine
The protection rate will be calculated based on the reported cases occurred 30 days after injection.
Time frame: ≥30 cases reported after 30 days of the injection
The incidences of adverse events (AEs) of each group
AEs occurred within 30 days after injection will be collected.
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 6 months after injection will be collected.
Time frame: 6 months
The seroconversion rate of the immunogenicity group
Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
Time frame: 30 days after injection
The geometric mean titer (GMT) of the immunogenicity group
Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
Time frame: 30 days
The geometric mean fold increase (GMI) of the immunogenicity group
Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.
Time frame: 30 days after injection
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