This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.
This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13\~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would be randomly divided into experimental group and control group according to 1:1 ratio, and subjects will receive two doses of vaccine with the immunization course of 0,28 days or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,480
live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection
live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection
Henan Provincial Center for Disease Prevention and Control
Zhenzhou, Henan, China
Seroconversion rate of HI antibody
The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.
Time frame: Day 42 after the whole schedule
GMT of HI antibody
The GMT of the antibody 42 days among all subjects after the second vaccination.
Time frame: Day 42 after the whole schedule
Seroprotection rate of HI antibody
The seroprotection rate of the antibody 42 days among all subjects after the second vaccination.
Time frame: Day 42 after the whole schedule
Incidence of adverse reactions within 30 minutes after each dose
Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.
Time frame: Within 30 minutes after each dose
Incidence of adverse reactions within 0~28 days after each dose
Incidence of adverse reactions within 0\~28 days after each dose vaccination with immunization course of 0,28 days and 0,56 days.
Time frame: Within 0~28 days after each dose
Incidence of serious adverse events
Incidence of serious adverse events from vaccination to 6 months after the second vaccination with immunization course of 0,28 days and 0,56 days
Time frame: From vaccination to 6 months after the second vaccination
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