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This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.
This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine . |
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| Control Group | Active Comparator | 600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dosage SARS-CoV-2 vaccine | Biological | SARS-CoV-2 Inactivated Vaccine 1200SU inactivated 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) 28 days after booster vaccination. | Day 28 after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-seropositive rate of neutralizing antibodies(CZ02 strain) | The seropositive rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-the seropositive rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) | The seroconversion rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination | 6 months after the booster vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongxing Pan, Master | Jiangsu Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinqi City Center for Disease Control and Prevention | Xinqi | Jiangsu | 221400 | China |
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|
| Medium-dosage SARS-CoV-2 vaccine | Biological | SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection |
|
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The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination |
| Day 28 after booster vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) | GMI of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-seropositive rate of neutralizing antibodies(Delta Strain) | The seropositive rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta Strain) | The seroconversion rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(Delta Strain) | GMI of neutralizing antibodies(Delta Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain) | The seroconversion rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-seropositive rate of neutralizing antibodies(Omicron Strain) | The seropositive rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain) | GMI of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain) | GMT of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
| Immunogenicity index-GMT of neutralizing antibodies(Delta Strain) | GMT of neutralizing antibodies(Delta Strain) 28 days after booster vaccination | Day 28 after booster vaccination |
GMI of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination |
| 6 months after the booster 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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