Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multi-center and open design, phase â…£ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in population aged 3~17 years and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.
This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 3~17 years . The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in 11 provinces from August 2021 to December 2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing, Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research center will select the corresponding research site.A total of 33000 subjects including patients with pre-existing will be enrolled with 3000 for each research center, including 600 subjects aged 3~5years，1200 subjects aged 6~11 years,1200 subjects aged 12~17 years.
And subjects will receive two doses of vaccine on day 0 and day 28.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | All of the participants(N=33000) will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group | Biological | SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety index 1-incidence of adverse reactions | Incidence rate of adverse reactions within 0~7 days after each dose in all populations. | Within 0~7 days after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index 2-incidence of adverse reactions | Incidence rate of adverse reactions within 0~28 days after each dose in all populations | Within 0-28 days after each dose vaccination |
| Safety index 3-incidence of adverse reactions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaoqiang Liu, Doctor | Yunnan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Xing Fang | Liaoning Provincial Center for Disease Control and Prevention | Principal Investigator |
| Zhaodan Sun | HeilongjiangProvincial Center for Disease Control and Prevention | Principal Investigator |
| Fubing Wang | Hefei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Dongjuan Zhang | Center for Disease Control and Prevention, Fujian | Principal Investigator |
| Shicheng Guo | Jiangxi Provincial Center for Disease Control and Prevention | Principal Investigator |
| Yeqing Tong | Hubei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Qiuyun Deng | Guangxi Center for Disease Control and Prevention | Principal Investigator |
| Qing Wang | Chongqing Center for Disease Control and Prevention |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongping Center for Diseases Control and Prevention | Dali | Yunnan | 650022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36658045 | Derived | Yang H, Li Z, Zhang R, Guo S, Wang B, Fang X, Zhang D, Zhang X, Tong Y, Wang Q, Deng Q, Sun Z, Liu X, Gao Y. Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac(R)) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China. Vaccine. 2023 Feb 10;41(7):1354-1361. doi: 10.1016/j.vaccine.2023.01.020. Epub 2023 Jan 13. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Incidence of adverse reactions within 0~7 days after each dose in each age group
| Within 0~7 days after each dose vaccination |
| Safety index 4-incidence of adverse reactions | Incidence rate of adverse reactions within 0~28 days after each dose in each age group | Within 0~28 days after each dose vaccination |
| Safety index 5-incidence of adverse reactions | Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease. | Within 0~7 days after each dose vaccination |
| Safety index 6-incidence of adverse reactions | Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease. | Within 0~28 days after each dose vaccination |
| Principal Investigator |
| Ruizhi Zhang | Guizhou Provincial Center for Disease Control and Prevention | Principal Investigator |
| Xiaoshu Zhang | Gansu Provincial Center for Disease Control and Prevention | Principal Investigator |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |