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COVID-19Phase 3NCT05137418

Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years

A Phase 3 study testing COVID-19 Vaccine,Inactivated in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

Completed

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

Official record
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Trial summary

This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years. Read more about this study

Who is it for?
Ages 3 to 11 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
COVID-19 Vaccine,Inactivated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteChina
Study dates
27 Nov 2021to 27 Jan 2023
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 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy participants aged 3-11 years;
  • The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations)(For subjects aged 3-7years ,guardians need to sign the informed consent form,for subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form);
  • Able to comply with study procedures based on the assessment of the Investigator
  • Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

Who cannot join

  • History of SARS-CoV-2 infection;
  • Close contact with a confirmed COVID-19 within 14 days prior to randomization;
  • Prior administration of an investigational coronavirus vaccine or current/ planned simultaneous participation in another interventional study to prevent or treat COVID-19;
  • Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
  • Personal or first-grade relative (siblings) history of multisystem inflammatory disease in children (MIS-C);
  • Significant chronic illnesses that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but are not limited to cardiovascular disease, liver or kidney disorders, respiratory illnesses);
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  • Significant chronic central nervous system diseases or neuromuscular disorders, psychosis or severe cognitive behavioral disorder, in the opinion of the investigator, including epilepsy, autism spectrum disorder, intellectual disabilities (excluding Down Syndrome);
  • Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
  • History of autoimmune and/or haematological diseases (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, any form of malignant tumor, asplenia, functional asplenia, or splenectomy resulting from any condition); well controlled type I diabetes mellitus is allowed;
  • History of bleeding disorders (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture;
  • Immunosuppressive therapy (systemic corticoid therapy, e.g. prednisone
  • ≥2 mg/Kg/d or ≥20 mg/day for >14 days), cytotoxic therapy (antineoplastic chemotherapy, radiation therapy), (excluding topical or aerosol corticosteroid therapy) in the past 6 months;
  • Receipt of blood products or immunoglobulins in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc;
  • Acute febrile illness with oral temperature >37.7°C ,enrollment could be considered if the fever is absent for 72 hours;
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection;
  • Children in care or under a court order;
  • According to the investigator's judgment, the subject has any other factors that might interfere with the results of the clinical trial or pose additional risk to the subject due to participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sheyang County Center for Disease Control and Prevention

    Yancheng, Jiangsu, 224300

Other trials in China

About this study

Official title: An Open-labelled, Bridging Phase Ⅲ Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine in Healthy Population Aged From 3 to 11 Years

This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.

Read the detailed description

This study is a single-center, open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine.The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.This study (PRO-nCOV-3002-1) will be used as a sub-trial of the Phase Ⅲ global multi-center clinical trial in children and adolescents(PRO-nCOV-3002) to provide safety and immunogenicity data.A total of 1000 healthy children aged 3-11 years will be enrolled ,including 500 children aged 3-5 years and 500 children aged 6-11 years.All subjects will receive 2 doses of experimental vaccine (600SU) with an interval of 28 days,and adverse reactions/events will be collected from all subjects after each dose and SAE and AESI monitoring will be completed from the beginning of vaccination to 6 and 12 months after full vaccination to evaluate the safety of the vaccine.About 3.0-3.5ml of venous blood will be collected from all subjects before immunization, 28 days after the whole immunization, 6 months after the whole immunization and 12 months after the whole immunization. Neutralizing antibody and S antibody will be detected to evaluate the immunogenicity and immune persistence of the vaccine.

Conditions
COVID-19
Being tested
COVID-19 Vaccine,Inactivated
Medical subject headings
COVID-19

What participants receive

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

  • COVID-19 Vaccine,InactivatedBiological

    Also called CoronaVac

    The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection

Study groups in NCT05137418
Study groupRoleWhat they receive
3-5 years old age groupExperimental500 participants aged 3-5 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28.
Receives: Biological: COVID-19 Vaccine,Inactivated
6-11 years old age groupExperimental500 participants aged 6-11 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28.
Receives: Biological: COVID-19 Vaccine,Inactivated

What is being measured

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

  1. Immunogenicity index-the GMT of neutralizing antibodies

    The GMT of neutralizing antibodies 28 days after the second vaccination.

    Measured: 28 days after the second vaccination

Secondary outcomes (14)

  1. Immunogenicity index-the seroconversion rate of neutralizing antibodies

    The seroconversion rate of neutralizing antibodies 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  2. Immunogenicity index-the seropositive rate of neutralizing antibodies 28 days after the second vaccination

    The seropositive rate of neutralizing antibodies 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  3. Immunogenicity index-GMI of neutralizing antibodies

    GMI of neutralizing antibodies 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  4. Immunogenicity index-The seroconversion rate of the S antibody to SARS-CoV-2

    The seroconversion rate of the S antibody to SARS-CoV-2 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  5. Immunogenicity index-The seropositivity rate of the S antibody to SARS-CoV-2

    The seropositivity rate of the S antibody to SARS-CoV-2 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  6. Immunogenicity index-GMC of the S antibody to SARS-CoV-2

    GMC of the S antibody to SARS-CoV-2 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  7. Immunogenicity index-GMI of the S antibody to SARS-CoV-2

    GMI of the S antibody to SARS-CoV-2 28 days after the second vaccination

    Measured: 28 days after the second vaccination

  8. Immunogenicity index-The seropositive rate of neutralizing antibodies

    The seropositive rate of neutralizing antibodies 6 months/12 months days after the second vaccination

    Measured: 6 months/12 months days after the second vaccination

  9. Immunogenicity index-GMT of neutralizing antibodies

    GMT of neutralizing antibodies 6 months/12 months days after the second vaccination

    Measured: 6 months/12 months days after the second vaccination

  10. Immunogenicity index-The seropositivity rate of the S antibody to SARS-CoV-2

    The seropositivity rate of the S antibody to SARS-CoV-2 6 months/12 months days after the second vaccination

    Measured: 6 months/12 months days after the second vaccination

  11. Immunogenicity index-GMC of the S antibody to SARS-CoV-2

    GMC of the S antibody to SARS-CoV-2 6 months/12 months days after the second vaccination

    Measured: 6 months/12 months days after the second vaccination

  12. Safety index-Incidence rate of adverse reactions

    Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose vaccination

    Measured: From the beginning of the vaccination to 28 days after the second dose vaccination

  13. Safety index-Incidence rate of SAEs

    Incidence rate of SAEs from the beginning of the vaccination to 6 months after the second dose vaccination.

    Measured: From the beginning of the vaccination to 6 months after the second dose vaccination

  14. Safety index-Incidence rate of AESIs

    Incidence rate of AESIs from the beginning of the vaccination to 6 months after the second dose vaccination

    Measured: From the beginning of the vaccination to 6 months after the second dose vaccination

Timeline

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

  1. First posted30 Nov 2021
  2. Study start27 Nov 2021
  3. Primary completion27 Jan 2023
  4. Study completion27 Jan 2023

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05137418
Sponsor's protocol ID
PRO-nCOV-3002-1
Status last verified
Oct 2023
First submitted
26 Nov 2021
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing COVID-19 Vaccine,Inactivated in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

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 4 inclusion and 21 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 16 Oct 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 China. 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?

Immunogenicity index-the GMT of neutralizing antibodies (time frame: 28 days after the second vaccination). 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 NCT05137418.

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 16 Oct 2023.

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