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This an open-label phase â…£ clinical trial of live attenuated varicella vaccine 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 6 and 10 years after booster dose.
A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase â…¢ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Subjects will be collected venous blood at 6 and 10 years after booster immunization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Attenuated Varicella Vaccine | Biological | lyophilized powder, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive rate | The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination | at 6 years after booster vaccination |
| Seropositive rate | The seropositive rate of VZV antibodies at 10 years after booster vaccination | at 10 years after booster vaccination |
| GMT of VZV antibody | The GMT of VZV antibodies at 6 years after booster vaccination | at 6 years after booster vaccination |
| GMT of VZV antibody | The GMT of VZV antibodies at 10 years after booster vaccination | at 10 years after booster vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lili Huang | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Center for Disease Control and Prevention | Zhengzhou | Henan | 450016 | China |
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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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| D007239 | Infections |