Covid19 Clinical Trial
— COVID-19Official title:
A Immunobridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated in Population Aged ≥ 60 Years Old and 3-17 Years Old Compared With That in Population Aged 18-59 Years Old
Verified date | June 2023 |
Source | China National Biotec Group Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 4400 |
Est. completion date | March 31, 2024 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Yanjin County Center for Disease Control and Prevention | Xinxiang | Henan |
Lead Sponsor | Collaborator |
---|---|
China National Biotec Group Company Limited | Beijing Institute of Biological Products Co Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Immune Persistence | Neutralizing antibody assay will be performed using the Microcytopathic assay | 18 months and 24 months after the full immunization | |
Primary | 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 | |
Primary | The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | =4 fold increase from baseline | 14 days after the full course immunization | |
Secondary | 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 | |
Secondary | The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | =4 fold increase from baseline | 14 days after the second dose in schedule of Day 0,21,42 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Immune Persistence | Neutralizing antibody assay will be performed using the Microcytopathic assay | 3 months, 6 months, 12 months after the full course immunization | |
Secondary | 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 | |
Secondary | 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 |
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