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

China National Biotec Group (CNBG)

Status and phase: Active, not recruiting; Phase 4

Conditions: Covid19

Treatments: Biological: 2 doses of vaccine; Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated; Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated; Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

Study type: Interventional

Funder types: Industry

Identifiers

NCT04863638

BIBP2020004CN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,400 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,400 participants in 18 patient groups

A1 aged ≥ 71

Experimental group

Description:

300 subjects age ≥ 71 （A1）receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

A2 aged ≥ 71

Experimental group

Description:

200 subjects age ≥ 71 （A2）receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

A3 aged ≥ 71

Experimental group

Description:

200 subjects age ≥ 71 (A3) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

B1 aged 60-70

Experimental group

Description:

300 subjects age 60-70 (B1) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

B2 aged 60-70

Experimental group

Description:

200 subjects age 60-70 (B2) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

B3 aged 60-70

Experimental group

Description:

200 subjects age 60-70 (B3) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

C1 aged 18-59

Experimental group

Description:

300 subjects age 18-59 (C1) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

C2 aged 18-59

Experimental group

Description:

200 subjects age 18-59 (C2) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

C3 aged 18-59

Experimental group

Description:

200 subjects age 18-59 (C3) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

C4 aged 18-59

Experimental group

Description:

300 subjects age 18-59 (C4) receive 2 doses of vaccine

Treatment:

Biological: 2 doses of vaccine

D1 aged 9-17

Experimental group

Description:

300 subjects age 9-17 (D1) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

D2 aged 9-17

Experimental group

Description:

200 subjects age 9-17 (D2) receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

D3 aged 9-17

Experimental group

Description:

200 subjects age 9-17 （D3）receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

D4 aged 9-17

Experimental group

Description:

300 subjects age 9-17 （D4）receive 2 doses of vaccine

Treatment:

Biological: 2 doses of vaccine

E1 aged 3-8

Experimental group

Description:

300 subjects age 3-8 （E1） receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

E2 aged 3-8

Experimental group

Description:

200 subjects age 3-8 （E2）receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

E3 aged 3-8

Experimental group

Description:

200 subjects age 3-8 （E3）receive 3 doses of vaccine

Treatment:

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

E4 aged 3-8

Experimental group

Description:

300 subjects age 3-8 （E4）receive 2 doses of vaccine

Treatment:

Biological: 2 doses of vaccine