Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 aged ≥ 71 | Experimental | 300 subjects age ≥ 71 (A1)receive 3 doses of vaccine |
|
| A2 aged ≥ 71 | Experimental | 200 subjects age ≥ 71 (A2)receive 3 doses of vaccine |
|
| A3 aged ≥ 71 | Experimental | 200 subjects age ≥ 71 (A3) receive 3 doses of vaccine |
|
| B1 aged 60-70 | Experimental | 300 subjects age 60-70 (B1) receive 3 doses of vaccine |
|
| B2 aged 60-70 | Experimental | 200 subjects age 60-70 (B2) receive 3 doses of vaccine |
|
| B3 aged 60-70 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated | Biological | the schedule of Day 0, 21, 42 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | Neutralizing antibody assay will be performed using the Microcytopathic assay | 14 days after the full course immunization |
| The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | ≥4 fold increase from baseline | 14 days after the full course immunization |
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | Neutralizing antibody assay will be performed using the Microcytopathic assay | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Persistence | Neutralizing antibody assay will be performed using the Microcytopathic assay | 18 months and 24 months after the full immunization |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang, Bachelor | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanjin County Center for Disease Control and Prevention | Xinxiang | Henan | 453200 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
200 subjects age 60-70 (B3) receive 3 doses of vaccine |
|
| C1 aged 18-59 | Experimental | 300 subjects age 18-59 (C1) receive 3 doses of vaccine |
|
| C2 aged 18-59 | Experimental | 200 subjects age 18-59 (C2) receive 3 doses of vaccine |
|
| C3 aged 18-59 | Experimental | 200 subjects age 18-59 (C3) receive 3 doses of vaccine |
|
| C4 aged 18-59 | Experimental | 300 subjects age 18-59 (C4) receive 2 doses of vaccine |
|
| D1 aged 9-17 | Experimental | 300 subjects age 9-17 (D1) receive 3 doses of vaccine |
|
| D2 aged 9-17 | Experimental | 200 subjects age 9-17 (D2) receive 3 doses of vaccine |
|
| D3 aged 9-17 | Experimental | 200 subjects age 9-17 (D3)receive 3 doses of vaccine |
|
| D4 aged 9-17 | Experimental | 300 subjects age 9-17 (D4)receive 2 doses of vaccine |
|
| E1 aged 3-8 | Experimental | 300 subjects age 3-8 (E1) receive 3 doses of vaccine |
|
| E2 aged 3-8 | Experimental | 200 subjects age 3-8 (E2)receive 3 doses of vaccine |
|
| E3 aged 3-8 | Experimental | 200 subjects age 3-8 (E3)receive 3 doses of vaccine |
|
| E4 aged 3-8 | Experimental | 300 subjects age 3-8 (E4)receive 2 doses of vaccine |
|
| 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated | Biological | the schedule of Day 0, 21, 111 |
|
| 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated | Biological | the schedule of Day 0, 21, 171 |
|
| 2 doses of vaccine | Biological | the schedule of Day 0, 21 |
|
≥4 fold increase from baseline |
| 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 | 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 | 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 | 3 months, 6 months, 12 months after the full course immunization |
| Safety index-Incidence of adverse reactions | collect the all the adverse events using dairy card and contact card | 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 | From the beginning of the vaccination to 6 months after the full course immunization |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided