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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group with the immunization course of 0,28 days or 0,56 days | Experimental | 1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days. |
|
| Control Group | Active Comparator | 1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. | Biological | live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of HI antibody | The seroconversion rate of the antibody 42 days among all subjects after the second vaccination. | Day 42 after the whole schedule |
| GMT of HI antibody | The GMT of the antibody 42 days among all subjects after the second vaccination. | Day 42 after the whole schedule |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate of HI antibody | The seroprotection rate of the antibody 42 days among all subjects after the second vaccination. | Day 42 after the whole schedule |
| Incidence of adverse reactions within 30 minutes after each dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Center for Disease Prevention and Control | Zhenzhou | Henan | China |
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| Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd | Biological | live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection |
|
Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.
| 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. | 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 | 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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