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This study is an open-label phase โ ฃ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
This study is an open-label phase โ ฃ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 200 subjects in group A1 will receive one dose of booster immunization 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine. |
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| Control Group | Experimental | 200 subjects in group A2 will receive one dose of booster immunization 5 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine. |
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| Safety group | Experimental | 1000 subjects in group B will be enrolled and receive 1 dose of booster immunization more than 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Inactivated Vaccine | Biological | 600SU inactivated virus in 0ยท5 mL of aluminiumhydroxide solution per injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 | GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine. | 1 month after booster immunization |
| Safety index-incidence of adverse reactions | Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine | 1 month after booster immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of serious adverse events | Incidence rate of serious adverse events within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine | 1 month after booster immunization |
| Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Wu, Master | Contact | 13381081732 | wj81732@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Wu, Master | Beijing Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Centers for Diseases Control and Prevention | Recruiting | Beijing | 100013 | 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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| The SARS-CoV-2 Inactivated Vaccine | Biological | 600SU inactivated virus in 0ยท5 mL of aluminiumhydroxide solution per injection |
|
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Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine |
| 1 month after booster immunization |
| Seropositivity rate of IgG antibody | Seropositivity rate of IgG antibody within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine | 1 month after booster immunization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |