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A single-center, randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of booster vaccination of Recombinant COVID-19 variant vaccine (Sf9 cell) in healthy people aged 18 years and older after completing 2 or 3 doses of novel coronavirus inactivated vaccine (Vero cells)
two dose level of Recombinant COVID-19 variant vaccine (Sf9 cell) compete with Recombinant COVID-19 vaccine (CHO cell) and Recombinant COVID-19 vaccine (Sf9 cell) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose test group | Experimental | one dose, Day 0 |
|
| high dose test group | Experimental | one dose, Day 0 |
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| control group 1 | Active Comparator | one dose, Day 0 |
|
| control group 2 | Active Comparator | one dose, Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 variant vaccine (Sf9 cell) | Biological | WSK-V102 |
|
| Measure | Description | Time Frame |
|---|---|---|
| solicited adverse events (AE) | Incidence of solicited adverse events (AE) within 14 days after vaccination | within 14 days after vaccination |
| Primary Immunogenic indicator | Geometric Mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 Prototype and Omicron Variant 14 days after vaccination | 14 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| unsolicited adverse events | Incidence of unsolicited adverse events (AE) 0-30 days after vaccination | 0-30 days after vaccination |
| SAE | Incidence of serious adverse events (SAE), adverse events of Special Concern (AESI), and adverse events requiring medical attention (MAAE) within 12 months after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Prevention and Control | Nanjing | 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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| Recombinant COVID-19 vaccine (CHO cell) | Biological | control 1 |
|
| Recombinant COVID-19 vaccine (Sf9 cell) | Biological | control 2 |
|
| within 12 months after vaccination |
| GMT | Geometric mean Titer (GMT) of neutralizing Antibodies against SARS-CoV-2 prototype Strain and Omicron Variant Strain | 30 days, 3 months and 6 months after vaccination |
| GMI | Geometric mean growth multiple (GMI) of neutralizing antibody against SARS-CoV-2 prototype strain | 14, day 30, 3 and 6 months after vaccination |
| binding antibodies | Geometric Mean Titer (GMT) and Geometric mean Titer Increase Factor (GMI) of IgG Antibody against SARS-CoV-2 S-RBD protein | 14, day 30, 3 and 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 |