A Phase 3 interventional study of Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd and Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd in Varicella, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. · Phase 3, Interventional, and Prevention
This a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity of a two doses vaccination of investigational vaccine with 0,28 day, 0,42 day and 0,56 day immunization schedule in population aged ≥13 years old.
This study is a randomized, blind, controlled phase # clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 2400 subjects aged 13 years and older will be enrolled with1200 subjects in 13 \~ 17 years old group and1200 subjects in 18 years and older group.960 subjects in each age group will 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, 0,42 days or 0,56 days. An additional 240 subjects in each age group will be randomly divided into experimental group and control group according to 2:1 ratio to receive two doses of the experimental vaccine or placebo with the immunization course of 0, 70 days.In addition,400 subjects including 320 people of experimental group in different immunization course according to the difference of age and 80 people of placebo group according to the difference of age will be selected to collect blood about 3ml each time to evaluate immunity persistence of live attenuated varicella vaccines at 3 and 5 years after the whole immunization.
Exclusion Criteria:
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Biological: Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days.
Biological: Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days.
Biological: Placebo
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Sodium chloride and distilled water
Seroconversion rate of the antibody
The seroconversion rate of the antibody 28 days among all subjects after the second vaccination.
Time frame: Day 28 after the whole schedule
GMT of the antibody
The GMT of the antibody 28 days among all subjects after the second vaccination.
Time frame: Day 28 after the whole schedule
GMI of the antibody
GMI of the antibody 28 days among all subjects after the second vaccination.
Time frame: Day 28 after the whole schedule
Seroconversion rate, positive rate, GMT and GMI of the antibody
Seroconversion rate, positive rate, GMT and GMI of the antibody among all subjects on day 28,day 42 and day 56 after the first vaccination.
Time frame: Day 28,Day 42 and day 56 after the first vaccination
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 ,0,42 days and 0,56 days.
Time frame: Within 0~28 days after each dose
Incidence of adverse reactions within 0~14 days after each dose vaccination
Incidence of adverse reactions within 0\~14 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days
Time frame: Within 0~14 days after each dose
Incidence of grade 3 and above adverse reactions
Incidence of grade 3 and above adverse reactions within 0\~28 days after each dose vaccination with immunization course of 0,28 days ,0,42 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 ,0,42 days and 0,56 days
Time frame: From vaccination to 6 months after the second vaccination
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Sinovac (Dalian) Vaccine Technology Co., Ltd.