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

Primary Purpose

Covid19

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
China National Biotec Group Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Yanjin County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A1 aged ≥ 71

A2 aged ≥ 71

A3 aged ≥ 71

B1 aged 60-70

B2 aged 60-70

B3 aged 60-70

C1 aged 18-59

C2 aged 18-59

C3 aged 18-59

C4 aged 18-59

D1 aged 9-17

D2 aged 9-17

D3 aged 9-17

D4 aged 9-17

E1 aged 3-8

E2 aged 3-8

E3 aged 3-8

E4 aged 3-8

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline

Secondary Outcome Measures

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Immune Persistence
Neutralizing antibody assay will be performed using the Microcytopathic assay
Safety index-Incidence of adverse reactions
collect the all the adverse events using dairy card and contact card
Safety index-Incidence of serious adverse events
All SAEs will be collected

Full Information

First Posted
April 27, 2021
Last Updated
June 15, 2023
Sponsor
China National Biotec Group Company Limited
Collaborators
Beijing Institute of Biological Products Co Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04863638
Brief Title
A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated
Acronym
COVID-19
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Beijing Institute of Biological Products Co Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1 aged ≥ 71
Arm Type
Experimental
Arm Description
300 subjects age ≥ 71 (A1)receive 3 doses of vaccine
Arm Title
A2 aged ≥ 71
Arm Type
Experimental
Arm Description
200 subjects age ≥ 71 (A2)receive 3 doses of vaccine
Arm Title
A3 aged ≥ 71
Arm Type
Experimental
Arm Description
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
Arm Title
B1 aged 60-70
Arm Type
Experimental
Arm Description
300 subjects age 60-70 (B1) receive 3 doses of vaccine
Arm Title
B2 aged 60-70
Arm Type
Experimental
Arm Description
200 subjects age 60-70 (B2) receive 3 doses of vaccine
Arm Title
B3 aged 60-70
Arm Type
Experimental
Arm Description
200 subjects age 60-70 (B3) receive 3 doses of vaccine
Arm Title
C1 aged 18-59
Arm Type
Experimental
Arm Description
300 subjects age 18-59 (C1) receive 3 doses of vaccine
Arm Title
C2 aged 18-59
Arm Type
Experimental
Arm Description
200 subjects age 18-59 (C2) receive 3 doses of vaccine
Arm Title
C3 aged 18-59
Arm Type
Experimental
Arm Description
200 subjects age 18-59 (C3) receive 3 doses of vaccine
Arm Title
C4 aged 18-59
Arm Type
Experimental
Arm Description
300 subjects age 18-59 (C4) receive 2 doses of vaccine
Arm Title
D1 aged 9-17
Arm Type
Experimental
Arm Description
300 subjects age 9-17 (D1) receive 3 doses of vaccine
Arm Title
D2 aged 9-17
Arm Type
Experimental
Arm Description
200 subjects age 9-17 (D2) receive 3 doses of vaccine
Arm Title
D3 aged 9-17
Arm Type
Experimental
Arm Description
200 subjects age 9-17 (D3)receive 3 doses of vaccine
Arm Title
D4 aged 9-17
Arm Type
Experimental
Arm Description
300 subjects age 9-17 (D4)receive 2 doses of vaccine
Arm Title
E1 aged 3-8
Arm Type
Experimental
Arm Description
300 subjects age 3-8 (E1) receive 3 doses of vaccine
Arm Title
E2 aged 3-8
Arm Type
Experimental
Arm Description
200 subjects age 3-8 (E2)receive 3 doses of vaccine
Arm Title
E3 aged 3-8
Arm Type
Experimental
Arm Description
200 subjects age 3-8 (E3)receive 3 doses of vaccine
Arm Title
E4 aged 3-8
Arm Type
Experimental
Arm Description
300 subjects age 3-8 (E4)receive 2 doses of vaccine
Intervention Type
Biological
Intervention Name(s)
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
Intervention Description
the schedule of Day 0, 21, 42
Intervention Type
Biological
Intervention Name(s)
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
Intervention Description
the schedule of Day 0, 21, 111
Intervention Type
Biological
Intervention Name(s)
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
Intervention Description
the schedule of Day 0, 21, 171
Intervention Type
Biological
Intervention Name(s)
2 doses of vaccine
Intervention Description
the schedule of Day 0, 21
Primary Outcome Measure Information:
Title
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Description
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time Frame
14 days after the full course immunization
Title
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Description
≥4 fold increase from baseline
Time Frame
14 days after the full course immunization
Secondary Outcome Measure Information:
Title
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Description
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time Frame
14 days after the second dose in schedule of Day 0,21,42
Title
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Description
≥4 fold increase from baseline
Time Frame
14 days after the second dose in schedule of Day 0,21,42
Title
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Description
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time Frame
before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Title
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Description
≥4 fold increase from baseline
Time Frame
before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Title
Immune Persistence
Description
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time Frame
3 months, 6 months, 12 months after the full course immunization
Title
Safety index-Incidence of adverse reactions
Description
collect the all the adverse events using dairy card and contact card
Time Frame
From the beginning of the vaccination to 28 days after the full course immunization
Title
Safety index-Incidence of serious adverse events
Description
All SAEs will be collected
Time Frame
From the beginning of the vaccination to 6 months after the full course immunization
Other Pre-specified Outcome Measures:
Title
Immune Persistence
Description
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time Frame
18 months and 24 months after the full immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxia Wang, Bachelor
Organizational Affiliation
Henan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yanjin County Center for Disease Control and Prevention
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453200
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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