A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell) Inactivated

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    4400
  • sponsor
    China National Biotec Group Company Limited
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Updated on 23 May 2021
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Summary

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivatedand in population aged 60 years old and 3-17 years old with different 3-dose 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.

Description

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivatedand in population aged 60 years old and 3-17 years old with different 3-dose 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.

Details
Condition COVID19
Treatment 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated, 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated, 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated, 2 doses of vaccine
Clinical Study IdentifierNCT04863638
SponsorChina National Biotec Group Company Limited
Last Modified on23 May 2021

Eligibility

 Yes No Not Sure

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
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