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This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.
This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research & Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 (3-month interval) | Experimental | 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval). |
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| Experimental group 2 (4-month interval) | Experimental | 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval). |
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| Experimental group 3 (5-month interval) | Experimental | 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval). |
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| Experimental group 4 (6-month interval) | Experimental | 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine (Vero cell), Inactivated | Biological | The COVID-19 vaccine,inactivated was manufactured by Sinovac Research& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-GMT of neutralizing antibodies | GMT of neutralizing antibodies at 14 days after vaccination | At 14 days after vaccination |
| Immunogenicity index- GMT of neutralizing antibodies | GMT of neutralizing antibodies at 28 days after vaccination | At 28 days after vaccination |
| Safety index-Incidence of adverse reactions | Incidence of adverse reactions 0~28 days after vaccination | 0~28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index-seropositive rate of neutralizing antibodies | Seropositive rate of neutralizing antibodies of neutralizing antibodies before vaccination and at different points after vaccination | Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination |
| Immunogenicity index-GMT of neutralizing antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Yang, Master | Yunnan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongde Center for Diseases Control and Prevention | Lincang | Yunnan | 677600 | 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 |
|---|---|
| D000086663 | COVID-19 Vaccines |
| C000722216 | sinovac COVID-19 vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
GMT of neutralizing antibodies before vaccination and at different points after vaccination. |
| Day 0 before vaccination and 180 days after vaccination |
| Immunogenicity index-4-fold increase rate of neutralizing antibodies | 4-fold increase rate of neutralizing antibodies at different points after vaccination. | At 14 days and 28 days after vaccination. |
| Safety index-Incidence of adverse reactions | Incidence of adverse reactions 0~7 days after vaccination. | 0~7 days after vaccination |
| Safety index-Incidence of serious adverse events | Incidence of serious adverse events 6 months after vaccination. | 6 months after vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |