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This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.
This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 180 subjects (including 90 adults aged 18-59 years and 90 elderly aged 60 year and older)will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28 |
|
| Control Group | Placebo Comparator | 90 subjects (including 45 adults aged 18-59 years and 45 elderly aged 60 year and older)will receive one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated COVID-19 Vaccine | Biological | 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of the neutralizing antibody to SARS-CoV-2 | Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at day 28 after the second dose of inactivated COVID-19 vaccine | Day 28 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of the neutralizing antibody to SARS-CoV-2 | Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at different points after vaccination | Day 4, 14, 32,42 and 56 after the first dose |
| Seropositivity rate of the neutralizing antibody to SARS-CoV-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, Master | Shandong Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rushan City Center for Disease Control and Prevention | Weihai | Shandong | 250014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37325662 | Derived | Xu Q, Lu X, Liu X, Zhao Y, Sun D, Cao Q, Liu H, Yang T, Song Y, Lv J, Xiong P, Li J, Sun J, Xie M, Gao Y, Zhang L. Effect of an inactivated coronavirus disease 2019 vaccine, CoronaVac, on blood coagulation and glucose: a randomized, controlled, open-label phase IV clinical trial. Front Immunol. 2023 May 31;14:1122651. doi: 10.3389/fimmu.2023.1122651. eCollection 2023. |
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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 |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
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| 23-valent pneumococcal polysaccharide vaccine | Biological | 25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F |
|
| Inactivated Hepatitis A Vaccine | Biological | 500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection. |
|
Seropositivity rate of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination |
| Day 4, 14, 28, 32,42 and 56 after the first dose |
| GMT of the neutralizing antibody to SARS-CoV-2 | GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination | Day 4, 14, 28, 32,42 and 56 after the first dose |
| GMI of the neutralizing antibody to SARS-CoV-2 | GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination | Day 4, 14, 28, 32,42 and 56 after the first dose |
| Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) | Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine | Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine |
| Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) | Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine | Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine |
| Seroconversion rate of the hepatitis A antibody by Electrochemiluminescence | Seroconversion rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine | Day 28 after vaccination of Inactivated Hepatitis A Vaccine |
| Seropositivity rate of the hepatitis A antibody by Electrochemiluminescence | Seropositivity rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine | Day 28 after vaccination of Inactivated Hepatitis A Vaccine |
| GMT of the hepatitis A antibody by Electrochemiluminescence | GMT of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine | Day 28 after vaccination of Inactivated Hepatitis A Vaccine |
| GMI of the hepatitis A antibody by Electrochemiluminescence | GMI of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine | Day 28 after vaccination of Inactivated Hepatitis A Vaccine |
| Occurrence of abnormal changes of laboratory safety examinations | Occurrence of abnormal changes of laboratory safety examinations (Platelet factor 4 HIT, blood sugar, ESR, White blood cell count, hemoglobin, platelet count and Coagulation function index) | Day 4, 14, 28, 32,42 and 56 after the first dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |