Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04884685|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2021
Last Update Posted : July 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: SARS-CoV-2 Inactivated Vaccine Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial, to Evaluate the Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 3 to 17 Years.|
|Actual Study Start Date :||May 3, 2021|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||January 3, 2022|
Experimental: Experimental Group
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.
Biological: SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac
Placebo Comparator: Control Group
Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28.
aluminium hydroxide solution only
- Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose ]Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.
- Safety index-incidence of adverse reactions [ Time Frame: Day 0-7 after each dose vaccination ]Incidence rate of adverse reactions within 7 days after each dose
- Safety index-incidence of serious adverse events [ Time Frame: From the beginning of the vaccination to 6 months after the second dose vaccination ]Incidence rate of serious adverse events from the beginning of the vaccination to 6 months after the second dose vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884685
|Zanhuang county Center for Disease Control and Prevention|
|Shijiazhuang, Hebei, China, 051230|
|Principal Investigator:||Yuliang Zhao, Master||Hubei Provincial Center for Disease Control and Prevention|