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

June 15, 2023 updated by: China National Biotec Group Company Limited

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453200
        • Yanjin County Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A1 aged ≥ 71
300 subjects age ≥ 71 （A1）receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
Experimental: A2 aged ≥ 71
200 subjects age ≥ 71 （A2）receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
Experimental: A3 aged ≥ 71
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
Experimental: B1 aged 60-70
300 subjects age 60-70 (B1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
Experimental: B2 aged 60-70
200 subjects age 60-70 (B2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
Experimental: B3 aged 60-70
200 subjects age 60-70 (B3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
Experimental: C1 aged 18-59
300 subjects age 18-59 (C1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
Experimental: C2 aged 18-59
200 subjects age 18-59 (C2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
Experimental: C3 aged 18-59
200 subjects age 18-59 (C3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
Experimental: C4 aged 18-59
300 subjects age 18-59 (C4) receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21
Experimental: D1 aged 9-17
300 subjects age 9-17 (D1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
Experimental: D2 aged 9-17
200 subjects age 9-17 (D2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
Experimental: D3 aged 9-17
200 subjects age 9-17 （D3）receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
Experimental: D4 aged 9-17
300 subjects age 9-17 （D4）receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21
Experimental: E1 aged 3-8
300 subjects age 3-8 （E1） receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
Experimental: E2 aged 3-8
200 subjects age 3-8 （E2）receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
Experimental: E3 aged 3-8
200 subjects age 3-8 （E3）receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
Experimental: E4 aged 3-8
300 subjects age 3-8 （E4）receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after the full course immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
14 days after the full course immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after the full course immunization
≥4 fold increase from baseline
14 days after the full course immunization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety index-Incidence of serious adverse events
Time Frame: From the beginning of the vaccination to 6 months after the full course immunization
All SAEs will be collected
From the beginning of the vaccination to 6 months after the full course immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after the second dose in schedule of Day 0,21,42
Neutralizing antibody assay will be performed using the Microcytopathic assay
14 days after the second dose in schedule of Day 0,21,42
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after the second dose in schedule of Day 0,21,42
≥4 fold increase from baseline
14 days after the second dose in schedule of Day 0,21,42
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Neutralizing antibody assay will be performed using the Microcytopathic assay
before the third dose in schedules of Day 0,21,111 and Day 0,21,171
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
≥4 fold increase from baseline
before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Immune Persistence
Time Frame: 3 months, 6 months, 12 months after the full course immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
3 months, 6 months, 12 months after the full course immunization
Safety index-Incidence of adverse reactions
Time Frame: From the beginning of the vaccination to 28 days after the full course immunization
collect the all the adverse events using dairy card and contact card
From the beginning of the vaccination to 28 days after the full course immunization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immune Persistence
Time Frame: 18 months and 24 months after the full immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
18 months and 24 months after the full immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Biotec Group Company Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Institute of Biological Products Co Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanxia Wang, Bachelor, Henan Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIBP2020004CN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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