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This is a phase â…£ follow-up clinical trial based on the previous Phase â…£ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.
This study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older. The experimental vaccine is manufactured by Sinovac Life Sciences Co., Ltd.. A total of 180 healthy subjects received two dose of inactivated COVID-19 vaccine (CoronaVac) based on primary immunization in previous Phase Ⅳ clinical trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged 60 years and older.Subjects in each age group will receive the booster immunization of CoronaVac(the third dose) and will be collected blood sample before booster immunization and 14 days after booster immunization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult group | Experimental | 90 subjects aged 18-59 years received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine. |
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| Elderly group | Experimental | 90 elderly aged 60 year and older received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine. |
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| 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 |
|---|---|---|
| Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 | The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 | The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| GMT of neutralizing antibody against Prototype SARS-CoV-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, Master | 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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The GMT of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine. |
| 14 days after the booster immunization of inactivated COVID-19 vaccine |
| GMI of neutralizing antibody against Prototype SARS-CoV-2 | The GMI of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains | The seroconversion rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| Seropositive rate of neutralizing antibody against SARS-CoV-2 strains | The seropositive rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| GMI of neutralizing antibody against SARS-CoV-2 strains | The GMI of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| GMT of neutralizing antibody against SARS-CoV-2 strains | The GMT of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine. | 14 days after the booster immunization of inactivated COVID-19 vaccine |
| Seropositive rate of antibody against hepatitis A | Seropositive rate of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine. | 6-8 months after vaccination of Hepatitis A vaccine |
| GMC of antibody against hepatitis A | GMC of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine. | 6-8 months after vaccination of Hepatitis A vaccine |
| Incidence rate of adverse reactions | Incidence rate of adverse reactions within 0-28 days after booster immunization with COVID-19 vaccine. | 0-28 days after booster immunization with COVID-19 vaccine. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |