COVID-19 Clinical Trial
Official title:
Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years
Verified date | January 2022 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 immunogenicity of the CoronaVac in healthy children aged 3-11 years old.
Status | Completed |
Enrollment | 395 |
Est. completion date | December 30, 2022 |
Est. primary completion date | January 24, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 11 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Rushan City Center for Disease Control and Prevention | Weihai | Shandong |
Lead Sponsor | Collaborator |
---|---|
Sinovac Research and Development Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2 | Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine | Day 28(+14 days) after the second dose of vaccine | |
Primary | Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2 | GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine | Day 28(+14 days) after the second dose of vaccine |
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