Status:
UNKNOWN
A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Beijing Institute of Biological Products Co Ltd.
Conditions:
Covid19
Eligibility:
All Genders
3+ years
Phase:
PHASE4
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...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
4400 Patients enrolled
Trial Details
Trial ID
NCT04863638
Start Date
April 29 2021
End Date
March 31 2024
Last Update
June 18 2023
Active Locations (1)
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1
Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, China, 453200