Covid19
Conditions
Keywords
SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICAL3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
BIOLOGICAL3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
BIOLOGICAL3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
BIOLOGICAL2 doses of vaccine
the schedule of Day 0, 21
Sponsors
Beijing Institute of Biological Products Co Ltd.
China National Biotec Group Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 3 years and above (after enrolled, subjects will be allocated according to age). * By asking for medical history and physical examination, the health condition judged by the investigators is well. * Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion. * No vaccination history of COVID-19 vaccine before enrollment. * Be able and willing to complete the whole prescribed study plan. * With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.
Exclusion criteria
* Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check China Disease Prevention and Control Information System). * Has a history of SARS, MERS infection (self-report, on-site inquiry). * \>14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃. * Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred. * With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases. * Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases. * Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history. * With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease). * Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days). * Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination. * Received blood products within 3 months before enrolment. * Received other research drugs within 6 months before enrolment. * Other circumstances judged by investigators are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | 14 days after the full course immunization | ≥4 fold increase from baseline |
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | 14 days after the full course immunization | Neutralizing antibody assay will be performed using the Microcytopathic assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | 14 days after the second dose in schedule of Day 0,21,42 | ≥4 fold increase from baseline |
| Immune Persistence | 3 months, 6 months, 12 months after the full course immunization | Neutralizing antibody assay will be performed using the Microcytopathic assay |
| Safety index-Incidence of serious adverse events | From the beginning of the vaccination to 6 months after the full course immunization | All SAEs will be collected |
| Safety index-Incidence of adverse reactions | From the beginning of the vaccination to 28 days after the full course immunization | collect the all the adverse events using dairy card and contact card |
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | 14 days after the second dose in schedule of Day 0,21,42 | Neutralizing antibody assay will be performed using the Microcytopathic assay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune Persistence | 18 months and 24 months after the full immunization | Neutralizing antibody assay will be performed using the Microcytopathic assay |
Countries
China
Outcome results
None listed