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This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.
This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group of children aged 3-5 years old | Experimental | 200 subjects aged 3-5 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose |
|
| Experimental Group of children aged 6-11 years old | Experimental | 200 subjects aged 6-11 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated COVID-19 Vaccine | Biological | 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2 | Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine | Day 28(+14 days) after the second dose of vaccine |
| Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2 | GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine | Day 28(+14 days) after the second dose of vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Xu | Shandong Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rushan City Center for Disease Control and Prevention | Weihai | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |