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| Name | Class |
|---|---|
| Beijing Minhai Biotechnology Co., Ltd | INDUSTRY |
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
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This study is a randomized, double-blinded, and placebo controlled phase â…¡ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| candidate vaccine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Vaccine (Vero Cells), Inactivated | Biological | 2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose. Administer as an intramuscular injection into the lateral deltoid of the upper arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of SARS-CoV-2 neutralizing antibody | 28 days post full primary immunization course | |
| Geometric mean titer of SARS-CoV-2 neutralizing antibody | 28 days post full primary immunization course |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions/events | 0-28 days after each vaccination | |
| Serious Adverse Events (SAE) | within 12 months post full primary immunization course and the booster dose respectively | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guifan Li, M.S | Contact | +861059613591 | liguifan@biominhai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center for Diseases Control and Prevention | Changsha | Hunan | 410005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37967148 | Derived | Liu J, Huang B, Li G, Huang T, Wang D, Zhang L, Deng Y, Chang X, Liu Y, Li W, Zhang S, Huang W, Tan W, Gao L. Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine KCONVAC in Chinese Children: Randomized, Double-blind, Placebo-controlled Phase 1 and 2 Trials. Pediatr Infect Dis J. 2023 Dec 1;42(12):1136-1142. doi: 10.1097/INF.0000000000004085. Epub 2023 Sep 4. |
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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 |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Placebo | Biological | 2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval. |
|
| Seroconversion rate of SARS-CoV-2 IgG binding antibody |
| 28 days post full primary immunization course |
| Geometric mean titer of SARS-CoV-2 IgG binding antibody | 28 days, 3 months, 6 months and 12 months post full primary immunization course |
| Geometric mean titer of SARS-CoV-2 IgG binding antibody | 28 days, 3 months, 6 months and 12 months after the booster dose |
| Geometric mean titer of SARS-CoV-2 neutralizing antibody | 3 months, 6 months and 12 months post full primary immunization course |
| Geometric mean titer of SARS-CoV-2 neutralizing antibody | 28 days, 3 months, 6 months and 12 months after the booster dose |
| Seropositive rate of SARS-CoV-2 neutralizing antibody | 3 months, 6 months and 12 months post full primary immunization course |
| Seropositive rate of SARS-CoV-2 neutralizing antibody | 28 days, 3 months, 6 months and 12 months after the booster dose |
| Seropositive rate of SARS-CoV-2 IgG binding antibody | 3 months, 6 months and 12 months post full primary immunization course |
| Seropositive rate of SARS-CoV-2 IgG binding antibody | 28 days, 3 months, 6 months and 12 months after the booster dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |