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A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.
To evaluate safety of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and immunogenicity superiority of WSK-V101C to Recombinant COVID-19 vaccine (WSK-V101) after booster.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) |
|
| Control group | Active Comparator | Recombinant COVID-19 Vaccine (Sf9 Cell)(WSK-V101) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) | Biological | boost with Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) |
| Measure | Description | Time Frame |
|---|---|---|
| AE and AR | Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination. | 0-7 days after vaccination |
| Primary Immunogenicity indicator | The geometric mean titer (GMT) and seroconversion of neutralizing antibodies (true virus or pseudovirus method) against the current variants of SARS-CoV-2 (such as XBB and its subtypes) at day 14 post-vaccination. | day 14 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| AE and AR | Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination. | 0-30 days post-vaccination. |
| SAE and AE | Incidence of serious adverse events (SAE) and adverse events of specific interest (AESI) within 12 months post-vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101) | Biological | boost with Recombinant COVID-19 vaccine (Sf9 Cell) (WSK-V101) |
|
| within12 months post-vaccination. |
| Secondary Immunogenicity indicator 1 | Geometric mean titer (GMT) and seroconversion rate of neutralizing antibody (true virus or pseudovirus method) against SARS-CoV-2 prototype strain and Omicron BA.2 variant strain on day 14 post-vaccination. | day 14 post-vaccination. |
| Secondary Immunogenicity indicator 2 | Geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes), and Omicron BA.2 variants (true virus or pseudovirus method) on day 14 post-vaccination. | day 14 post-vaccination |
| Secondary Immunogenicity indicator 3 | Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes) and Omicron BA.2 variants neutralizing antibodies (true virus or pseudovirus method) at day 30 post-vaccination. | day 30 post-vaccination. |
| Secondary Immunogenicity indicator 4 | Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific binding antibodies at 14 and 30 days after vaccination. | 14 and 30 days post-vaccination. |
| 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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