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This study is a randomized, double-blinded, placebo-controlled, phase â…¡b clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.
This study is a randomized, double-blinded, placebo-controlled,phase â…¡b clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participant will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28. |
|
| Control Group | Placebo Comparator | Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Inactivated Vaccine | Biological | 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of adverse reactions | Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose. | Day 0-28 after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of adverse reactions | Incidence rate of adverse reactions within 7 days after each dose | Day 0-7 after each dose vaccination |
| Safety index-incidence of serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuliang Zhao, Master | Hubei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zanhuang county Center for Disease Control and Prevention | Shijiazhuang | Hebei | 051230 | 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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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
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| Placebo | Biological | aluminium hydroxide solution only |
|
Incidence rate of serious adverse events from the beginning of the vaccination to 6 months after the second dose vaccination.
| From the beginning of the vaccination to 6 months after the second dose vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |