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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 โฅ13 years old.
This study is a randomized, blind, controlled phase # clinical trial in population aged โฅ13 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group with the immunization course of 0,28 days, 0,42 days or 0,56 days | Experimental | 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. |
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| Control Group | Active Comparator | 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. |
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| Experimental Group with the immunization course of 0, 70 days | Experimental | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd | Biological | live varicella-zoster virus in 0ยท5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of the antibody | The seroconversion rate of the antibody 28 days among all subjects after the second vaccination. | Day 28 after the whole schedule |
| GMT of the antibody | The GMT of the antibody 28 days among all subjects after the second vaccination. | Day 28 after the whole schedule |
| Measure | Description | Time Frame |
|---|---|---|
| GMI of the antibody | GMI of the antibody 28 days among all subjects after the second vaccination. | Day 28 after the whole schedule |
| Seroconversion rate, positive rate, GMT and GMI of the antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lili Huang, Bachelor | Henan Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yucheng Center for Disease Control and Prevention | Shangqiu | Henan | 476300 | China |
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| Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd | Biological | live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection |
|
| Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd | Biological | live varicella-zoster virus in 0ยท5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection |
|
| Placebo | Biological | Sodium chloride and distilled water |
|
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.
| 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. | 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 | 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. | 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 | From vaccination to 6 months after the second vaccination |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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