The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
270
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China
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 abnormal results of lab tests
Cases of abnormal results of laboratory tests will be collected.
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after injection will be collected.
Time frame: 30 days
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