Varicella Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People
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. ;
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