This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules compared to that in population aged 18-59 years old with 2-dose schedule. And subjects in the same age are randomly assigned to different immunization schedule groups.
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,400
the schedule of Day 0, 21, 42
the schedule of Day 0, 21, 111
the schedule of Day 0, 21, 171
Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, China
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 14 days after the full course immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: 14 days after the full course immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 14 days after the second dose in schedule of Day 0,21,42
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: 14 days after the second dose in schedule of Day 0,21,42
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Immune Persistence
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 3 months, 6 months, 12 months after the full course immunization
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the schedule of Day 0, 21
Safety index-Incidence of adverse reactions
collect the all the adverse events using dairy card and contact card
Time frame: From the beginning of the vaccination to 28 days after the full course immunization
Safety index-Incidence of serious adverse events
All SAEs will be collected
Time frame: From the beginning of the vaccination to 6 months after the full course immunization