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This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months
This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated | Experimental | 170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated. |
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| Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated | Experimental | 170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dosage of COVID-19 vaccine (Vero cell), Inactivated | Biological | High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) | GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) | Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) | GMI of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingmei Feng, Master | Beijing YouAn Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Youan Hospital Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
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|
| Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated | Biological | Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection |
|
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The seroconversion rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination |
| 14 days after the booster dose vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) | GMT of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination | 7 days after the booster dose vaccination |
| Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) | Seropositivity rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination | 7 days after the booster dose vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) | GMI of neutralizing antibodies(CZ02 strain)7 days after the booster dose vaccination | 7 days after the booster dose vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) | The seroconversion rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination | 7 days after the booster dose vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) | GMT of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination | 28 days after the booster dose vaccination |
| Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) | Seropositivity rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination | 28 days after the booster dose vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) | GMI of neutralizing antibodies(CZ02 strain)28 days after the booster dose vaccination | 28 days after the booster dose vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) | The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination | 28 days after the booster dose vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) | GMT of neutralizing antibodies(CZ02 strain) 3 months after the booster dose vaccination | 3 months after the booster dose vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) | The seroconversion rate of neutralizing antibodies(CZ02 strain)3 months after the booster dose vaccination | 3 months after the booster dose vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) | GMT of neutralizing antibodies(CZ02 strain) 6 months after the booster dose vaccination | 6 months after the booster dose vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(Delta strain) | GMT of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-Seropositivity rate of neutralizing antibodies(Delta strain) | Seropositivity rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(Delta strain) | GMI of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta strain) | The seroconversion rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain) | GMT of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-Seropositivity rate of neutralizing antibodies(Omicron Strain) | Seropositivity rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain) | GMI of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain) | The seroconversion rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination | 14 days after the booster dose vaccination |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
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