A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated
NCT ID: NCT04863638
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
4400 participants
INTERVENTIONAL
2021-04-29
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A1 aged ≥ 71
300 subjects age ≥ 71 （A1）receive 3 doses of vaccine
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
A2 aged ≥ 71
200 subjects age ≥ 71 （A2）receive 3 doses of vaccine
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
A3 aged ≥ 71
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
B1 aged 60-70
300 subjects age 60-70 (B1) receive 3 doses of vaccine
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
B2 aged 60-70
200 subjects age 60-70 (B2) receive 3 doses of vaccine
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
B3 aged 60-70
200 subjects age 60-70 (B3) receive 3 doses of vaccine
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
C1 aged 18-59
300 subjects age 18-59 (C1) receive 3 doses of vaccine
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
C2 aged 18-59
200 subjects age 18-59 (C2) receive 3 doses of vaccine
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
C3 aged 18-59
200 subjects age 18-59 (C3) receive 3 doses of vaccine
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
C4 aged 18-59
300 subjects age 18-59 (C4) receive 2 doses of vaccine
2 doses of vaccine
the schedule of Day 0, 21
D1 aged 9-17
300 subjects age 9-17 (D1) receive 3 doses of vaccine
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
D2 aged 9-17
200 subjects age 9-17 (D2) receive 3 doses of vaccine
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
D3 aged 9-17
200 subjects age 9-17 （D3）receive 3 doses of vaccine
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
D4 aged 9-17
300 subjects age 9-17 （D4）receive 2 doses of vaccine
2 doses of vaccine
the schedule of Day 0, 21
E1 aged 3-8
300 subjects age 3-8 （E1） receive 3 doses of vaccine
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
E2 aged 3-8
200 subjects age 3-8 （E2）receive 3 doses of vaccine
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
E3 aged 3-8
200 subjects age 3-8 （E3）receive 3 doses of vaccine
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
E4 aged 3-8
300 subjects age 3-8 （E4）receive 2 doses of vaccine
2 doses of vaccine
the schedule of Day 0, 21
Interventions
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3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
2 doses of vaccine
the schedule of Day 0, 21
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
ALL
Yes
Sponsors
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Beijing Institute of Biological Products Co Ltd.
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Yanxia Wang, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Control and Prevention
Locations
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Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, China
Countries
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Other Identifiers
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BIBP2020004CN
Identifier Type: -
Identifier Source: org_study_id
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