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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
| Lanzhou Institute of Biological Products Co., Ltd | INDUSTRY |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVSI-06-09 Sequential Immunization Group | Experimental | the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months |
|
| Inactivated Vaccine Sequential Immunization Group | Active Comparator | the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-09) | Biological | Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-09) in the deltoid muscle of the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age | 14 days after sequential immunization of one booster dose | |
| the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age | 14 days after a single dose of the booster vaccine | |
| The incidence rate of any adverse reactions/events | within 30 minutes after vaccination | |
| The incidence severity of any adverse reactions/events | within 30 minutes after vaccination | |
| The incidence rate of solicited adverse reactions/events | within 0-7 days after vaccination | |
| The incidence severity of solicited adverse reactions/events | within 0-7 days after vaccination | |
| The incidence rate of solicited adverse reactions/events | within 8-30 days after vaccination | |
| The incidence severity of solicited adverse reactions/events | within 8-30 days after immunization | |
| The incidence of SAE observed | up to 12 months after full course of immunization | |
| The incidence of AESI observed |
| Measure | Description | Time Frame |
|---|---|---|
| 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age | 28 days after sequential immunization of one booster dose | |
| GMT of anti-omicron neutralizing antibody in adults ≥18 years of age | 28 days after sequential immunization of one booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of recombinant COVID-19 vaccine (CHO cell, NVSI-06-09) against COVID-19, severe cases and deaths after 14 days following sequential immunization in adults ≥18 years of age | During the study,an average of one and a half years | |
| Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age |
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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| Inactivated COVID-19 vaccine (Vero cells) | Biological | Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm |
|
| up to 12 months after full course of immunization |
| 4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age | 28 days after sequential immunization of one booster dose |
| GMT of anti-omicron IgG antibody in adults ≥18 years of age | before booster vaccination and 28 days after a single dose of the booster vaccine |
| 4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age | before booster vaccination and 28 days after a single dose of the booster vaccine |
| proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age | before booster vaccination and 28 days after a single dose of the booster vaccine |
| GMI of anti-omicron IgG antibody in adults ≥18 years of age | before booster vaccination and 28 days after a single dose of the booster vaccine |
| GMTs of anti-omicron neutralizing antibody | 3 months, 6 months, 9 months and 12 months after sequential immunization |
| IgG antibody of anti-omicron neutralizing antibody | 3 months, 6 months, 9 months and 12 months after sequential immunization |
| the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64 | 3 months, 6 months, 9 months and 12 months after sequential immunization |
| 14 days after a single dose of the booster vaccine |
| Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age | 28 days after a single dose of the booster vaccine |
| 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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