AzTrials
AzTrials

COVID-19 PneumoniaPhase 3COVID-19NCT04917523

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

A Phase 3 study testing SARS-CoV-2 Vaccine (Vero Cell), Inactivated in people with COVID-19 Pneumonia and COVID-19, run by China National Biotec Group Company Limited at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Pneumonia, COVID-19
What is being tested?
SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
1 siteUnited Arab Emirates
Study dates
2 Jul 2021to 29 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • Sheikh Khalifa Medical City, SEHA

    Abu Dhabi, 51900

Other trials in United Arab Emirates

About this study

Official title: 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

Read the 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.

Being tested
SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Keywords
SARS-CoV-2, SARS-CoV-2 Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 Vaccine (Vero Cell), InactivatedBiological

    0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen

Study groups in NCT04917523
Study groupRoleWhat they receive
Aged 3-6 years oldExperimental300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Receives: Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Aged 7-12 years oldExperimental300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Receives: Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Aged 13-17 years oldExperimental300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Receives: Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Aged ≥18 years oldActive comparator300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.
Receives: Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    ≥4 fold increase from baseline

    Measured: 28 days after 2 dose of immunization

  2. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Neutralizing antibody assay will be performed using the Microcytopathic assay

    Measured: 28 days after 2 dose of immunization

Secondary outcomes (5)

  1. Safety index-Incidence of adverse reactions

    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

    Measured: From the beginning of the vaccination to 28 days after the full course immunization

  2. Safety index-Incidence of serious adverse events

    All SAEs will be collected

    Measured: From the beginning of the vaccination to 6 months after the full course immunization

  3. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    ≥4 fold increase from baseline

    Measured: 28 days after booster dose of immunization

  4. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Neutralizing antibody assay will be performed using the Microcytopathic assay

    Measured: 28 days after booster dose of immunization

  5. The distribution of neutralizing antibody titer

    The proportions of neutralizing antibody titer

    Measured: 28 days after 2 dose of immunization and booster dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2021
  2. Study start2 Jul 2021
  3. Primary completion31 Mar 2022
  4. Study completion29 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04917523
Sponsor's protocol ID
CNBG2021001
Acronym
COVID-19
Status last verified
Jun 2023
First submitted
4 Jun 2021
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SARS-CoV-2 Vaccine (Vero Cell), Inactivated in people with COVID-19 Pneumonia and COVID-19, run by China National Biotec Group Company Limited at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody (time frame: 28 days after 2 dose of immunization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04917523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in