The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
This trial is aim to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children aged 1-12 years old. This study will be conducted in two stage. the stage 1 adopts an open design, and 20 subjects aged 18\~59 and 13\~17 years old (18\~59 years old→ 13\~17 years old, sequentially enrolled) are enrolled, and 1 dose of the trial vaccine is administered to explore safety. The stage 2 adopts a randomized, blinded, placebo-controlled design, 12400 healthy participants aged 1-12 years old will be randomly assigned into experimental group or control group with the ratio 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
12,440
0.5 ml/vial
0.5 ml/vial
Sinan County Center for Disease Control and Prevention
Tongren, Guizhou, China
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
The incidences of varicella in each group
The first 24 cases of varicella occurred 30 days after injection will be collected
Time frame: number of cases reported 30 days after vaccination
The efficacy of the live attenuated varicella vaccine
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
Time frame: number of cases reported 30 days after vaccination
The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
Time frame: number of cases reported 30 days after vaccination
The vaccine efficacy against clinical-confirmed cases
calculated based on the reported cases occurred 30 days after vaccination
Time frame: number of cases reported 30 days after vaccination
The incidences of adverse events (AEs)
AEs occurred within 30 days after injection will be collected
Time frame: within 30 days after vaccination
The incidences of serious adverse events (SAEs)
SAEs occurred within 6 months after vaccination will be collected
Time frame: at least 6 months after vaccination
The geometric mean titer (GMT) in the immunogenicity subgroup
Geometric mean titer (GMT) will be measured before and 30 days after vaccination
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Yuping Dong Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
Qi County Center for Disease Control and Prevention
Hebi, Henan, China
Wuzhi County Center for Disease Control and Prevention
Jiaozuo, Henan, China
Wuyang County Center for Disease Control and Prevention
Luohe, Henan, China
Pei County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Huaiyin District Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Mianyang Anzhou District Center for Disease Control and Prevention
Mianyang, Sichuan, China
Southern County Center for Disease Control and Prevention
Nanchong, Sichuan, China
...and 3 more locations
Time frame: 30 days after vaccination
The seroconversion rate of the immunogenicity subgroup
The seroconversion rate will be calculated before and 30 days after vaccination
Time frame: 30 days after vaccination
The geometric mean fold increase (GMI) of the immunogenicity subgroup
Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer
Time frame: 30 days after vaccination
The immune persistence of the immunogenicity subgroup
Geometric mean titer (GMT) will be measured
Time frame: 1 year, 2 years, and 3 years after vaccination