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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
| Lanzhou Institute of Biological Products Co., Ltd | INDUSTRY |
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This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 1-3 months, 3-6 months and ≥ 6 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject last vaccination time is within 30-90 days | Experimental | Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 30-90 days |
|
| Subject last vaccination time is within 91-180 days | Experimental | Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days |
|
| Subject last vaccination time more than 181 days | Experimental | Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 181 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Vaccine (CHO cell) | Biological | Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT of anti- SARS-CoV-2 neutralizing antibody | 14th day after vaccination | |
| GMT of anti- SARS-CoV-2 neutralizing antibody | 28th day after vaccination | |
| 4-fold rise of anti- SARS-CoV-2 neutralizing antibody | 14th day after vaccination | |
| 4-fold rise of anti- SARS-CoV-2 neutralizing antibody | 28th day after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of anti- SARS-CoV-2 neutralizing antibody | before vaccination | |
| GMT of anti-SARS-CoV-2 IgG antibody | 28th day after vaccination | |
| 4-fold rise of anti- SARS-CoV-2 neutralizing antibody |
| Measure | Description | Time Frame |
|---|---|---|
| The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths | 14th day after vaccination | |
| Anti-SARS-CoV-2 neutralizing antibody | 3th month, 6th month, 9th month and 12th month after full course of immunization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Khalifa Medical City | SEHA | Abu Dhab | 519000 | United Arab Emirates |
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| COVID-19 vaccine (Vero cells) | Biological | Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm |
|
| before vaccination |
| 4-fold rise of anti- SARS-CoV-2 neutralizing antibody | 28th day after vaccination |
| GMI of anti-SARS-CoV-2 IgG antibody | before vaccination |
| GMI of anti-SARS-CoV-2 IgG antibody | 28th day after vaccination |
| Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | before vaccination |
| Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | 28th day after vaccination |
| The incidence and serverity of any adverse reactions | within 30 minutes after vaccination |
| The incidence and serverity of solicited adverse events | within 30 minutes after vaccination |
| The incidence and severity of adverse reactions | within 0-7 days after vaccination |
| The incidence and serverity of solicited adverse events | within 0-7 days after vaccination |
| The incidence and severity of unsolicited adverse reactions | within 8-30 days after vaccination |
| The incidence and serverity of solicited adverse events | within 8-30 days after vaccination |
| The incidence of SAE observed | after vaccination and up to 6 months after full course of immunization |
| The incidence of AESI observed | after vaccination and up to 6 months after full course of immunization |
| Anti-SARS-CoV-2 GMT of IgG antibody | 3th month, 6th month, 9th month and 12th month after full course of immunization |
| Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | 3th month, 6th month, 9th month and 12th month after full course of immunization |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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