Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 vs Aged 18 Years Old and Above (COVID-19)

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

Immunogenicity Non-inferiority Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 Years Old vs Healthy Population Aged 18 Years Old and Above

This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) developed by Beijing Institute of Biological Products Co., Ltd in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above. Total of 1800 healthy volunteers aged 3 years old and above will be enrolled, of whom the subjects will be divided into two groups, 3-17 years old group and 18 years old and above group with each consisting of 900 volunteers. The 3-17 years old group was further divided into three subgroups: 3-6 years old, 7-12 years old and 13-17 years old, with 300 volunteers in each subgroup. 2 doses of vaccines will be injected into the deltoid muscle of either upper arm according to the immunization schedule of D0, D21 (+7 Days). Based on interim analysis'results of the booster dose administered to adults aged 18 years old and above, a booster dose might be introduced.

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.
1800

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 3

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

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:

  • Healthy subjects aged 3 years old and above
  • Medical history and physical examination of the subject confirms the subject is in a healthy condition and is approved by the investigator
  • Female subjects of childbearing age who 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.
  • The subject must be able and willing to complete the whole immunization schedule of the study and be able to follow up study procedures for 6 months.
  • With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent/ assent form. Legal authority or parents/guardians of minors 3-17 years should sign an informed consent form and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

  • Confirmed acute cases of SARS-CoV-2 infection.
  • With a medical history of SARS, MERS virus infection (self-report, on-site inquiry);
  • Fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before vaccination (Tympanic temperature / Temporal artery temperature >37.5 ℃);
  • Positive urine pregnancy test result.
  • Body temperature axillary ≥ 37.0 ℃ before vaccination（Tympanic temperature / Temporal artery temperature≥ 37.5 ℃);
  • With previous severe allergic reactions (such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of the inactivated SARS-CoV-2 vaccine.
  • With a medical history or a family history of convulsion, epilepsy, encephalopathy or mental illness.
  • With congenital malformation or developmental disorder, genetic defects, severe malnutrition, etc.;
  • With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 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; With a history of coagulation dysfunction (such as coagulation factor deficiency, coagulation disease);
  • With a history of coagulation dysfunction (such as coagulation factor deficiency coagulation disease);
  • Receiving anti-TB therapy.
  • Receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days);
  • Vaccinated live attenuated vaccine within 1 month before vaccination and other vaccines within 14 days before vaccination;
  • Received blood products within 3 months before vaccination;
  • Received other investigational drugs within 6 months before vaccination;
  • Other circumstances judged by investigators that were not suitable for participating in 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: Aged 3-6 years old
300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Experimental: Aged 7-12 years old
300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Experimental: Aged 13-17 years old
300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Active Comparator: Aged ≥18 years old
300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen

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 four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days after 2 dose of immunization
≥4 fold increase from baseline
28 days after 2 dose of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days after 2 dose of immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
28 days after 2 dose of 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 adverse reactions
Time Frame: From the beginning of the vaccination to 28 days after the full course immunization
the adverse event at injection site and systemic adverse event and other adverse events of the subjects are actively followed up and recorded in the subject diary card or follow-up calls
From the beginning of the vaccination to 28 days after the full course immunization
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 four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days after booster dose of immunization
≥4 fold increase from baseline
28 days after booster dose of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days after booster dose of immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
28 days after booster dose of immunization
The distribution of neutralizing antibody titer
Time Frame: 28 days after 2 dose of immunization and booster dose
The proportions of neutralizing antibody titer
28 days after 2 dose of immunization and booster dose

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: Nawal Al Kaabi, MD, Sheikh Khalifa Medical City

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.
July 2, 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.
March 31, 2022

Study Completion (Actual)

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.
April 29, 2022

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).
June 4, 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.
June 4, 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.
June 8, 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.
  • CNBG2021001

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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