COVID-19
Conditions
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 immunogenicity of the CoronaVac in healthy children aged 3-11 years old.
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 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 will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.
Interventions
BIOLOGICALInactivated COVID-19 Vaccine
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Sponsors
Sinovac Research and Development Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2 | Day 28(+14 days) after the second dose of vaccine | Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine |
| Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2 | Day 28(+14 days) after the second dose of vaccine | GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine |
Countries
China
Outcome results
None listed