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This an open phase โ ฃ clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 5 and 8 years after primary immunization with live attenuated varicella vaccine.
This study is an open phase โ ฃ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization. |
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| Control Group | Placebo Comparator | 354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Live Attenuated Varicella Vaccine | Biological | The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0ยท5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-seropositive rates of varicella antibody | The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine | 5 years after primary immunization |
| Immunogenicity index-GMT of varicella antibody | GMT of varicella antibody in 5 years after primary immunization with varicella vaccine | 5 years after primary immunization |
| Immunogenicity index-the seropositive rates of varicella antibody | The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine | 8 years after primary immunization |
| Immunogenicity index-the GMT of varicella antibody | GMT of varicella antibody in 8 years after primary immunization with varicella | 8 years after primary immunization |
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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 |
|---|---|---|---|---|---|---|
| Xiangcheng County Center for Disease Control and Prevention | Xuchang | Henan | 461700 | China | ||
| Biyang County Center for Disease Control and Prevention |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Placebo (Freeze Dired Dilution) | Biological | The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0ยท5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate. |
|
| Zhumadian |
| Henan |
| 463700 |
| China |
| D007239 | Infections |