Status:
COMPLETED
Immunogenicity of an Inactivated COVID-19 Vaccine
Lead Sponsor:
Sinovac Research and Development Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
3-11 years
Phase:
PHASE4
Brief Summary
This study is an open 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 immu...
Detailed Description
This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who hav...
Eligibility Criteria
Inclusion
- Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);
- The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;
- Proven legal identity.
Exclusion
- Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);
- Have received COVID-19 vaccines from other manufacturers;
- The interval between blood collection and the second dose is less than 28 days or more than 42 days;
- The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Key Trial Info
Start Date :
January 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT05198336
Start Date
January 8 2022
End Date
December 30 2022
Last Update
September 25 2023
Active Locations (1)
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1
Rushan City Center for Disease Control and Prevention
Weihai, Shandong, China, 250014