AzTrials
AzTrials

COVID-19Phase 4NCT05107557

Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)

A Phase 4 study testing Experimental Group in people with COVID-19, run by Sinovac Biotech Co., Ltd at 2 sites in China.

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 study is a randomized and controlled Phase IV clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71… Read more about this study

Who is it for?
Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Experimental Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
2 sitesChina
Study dates
5 Nov 2021to 14 Jul 2022
Phase
Phase 4
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 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 3-5 years;
  • The subject and/or guardian can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Who cannot join

  • History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
  • History of multiple system inflammatory syndrome (MIS-C);
  • History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;
  • History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
  • Congenital malformations or developmental disorders, genetic defects,severe malnutrition, etc.;
  • Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation);
Show all 20Show fewer
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy,abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of drug abuse;
  • Receipt of blood products within 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;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Axillary temperature >37.0°C;
  • The subjects participated in other clinical trials during the follow-up period,or will be planned within 3 months;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Yangchun City Center for Disease Control and Prevention

    Yangchun, Guangdong, 529699

  • Zhanjiang Center for Diseases Control and Prevention

    Zhenjiang, Guangdong, 524005

Other trials in China

About this study

Official title: A Randomized and Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Co-administrated With EV71 Vaccine (Vero Cell) in Children Aged 3-5 Years Old

This study is a randomized and controlled Phase IV clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine

Read the detailed description

This study is a randomized and controlled phase IV clinical trial in children aged 3-5 years old. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine.The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd and the EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 520 subjects aged 3-5 years old will be enrolled.Subjects will be randomly divided into 2 groups in a ratio of 1:1.The experimental group is the combined immunization group, which will receive the first dose of COVID-19 vaccine and the first dose of EV71 vaccine on day 0 and the second dose of COVID-19 vaccine and EV71 vaccine on day 28;Control group is the Non-combined immunization group , which will receive the first dose of COVID-19 vaccine on day 0 ,the first dose of EV71 vaccine on day 14, the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.

Conditions
COVID-19
Being tested
Experimental Group
Medical subject headings
COVID-19

What participants receive

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

  • Experimental GroupBiological

    Also called Combined immunization group

    The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.

Study groups in NCT05107557
Study groupRoleWhat they receive
Experimental GroupExperimentalThe experimental group is also called the combined immunization group.260 participants will receive the first dose of COVID-19 vaccine and EV71 vaccine on day 0 and the second dose of COVID-19 vaccine and EV71 vaccine on day 28.
Receives: Biological: Experimental Group
Control GroupActive comparatorThe control group is also called the Non-combined immunization group.260 participants will receive the first dose of COVID-19 vaccine on day 0,the first dose of EV71 vaccine on day 14,the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.
Receives: Biological: Experimental Group

What is being measured

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

  1. Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2

    Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine

    Measured: Day 28 after the second dose of COVID-19 vaccine

  2. Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71

    Seroconversion rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71 vaccine

    Measured: Day 28 after the second dose of EV71 vaccine

Secondary outcomes (9)

  1. Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2

    Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine.

    Measured: Day 28 after the second dose of COVID-19 vaccine

  2. Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2

    GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.

    Measured: Day 28 after the second dose of COVID-19 vaccine

  3. Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2

    GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.

    Measured: Day 28 after the second dose of COVID-19 vaccine

  4. Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71

    Seropositive rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71

    Measured: Day 28 after the second dose of EV71

  5. Immunogenicity index-GMT of the neutralizing antibody to EV71

    GMT of the neutralizing antibody to EV71 at day 28 after the second dose of EV71

    Measured: Day 28 after the second dose of EV71

  6. Immunogenicity index-GMI of the neutralizing antibody to EV71

    GMI of the neutralizing antibody to EV71 at day 28 after the second dose of EV71

    Measured: Day 28 after the second dose of EV71

  7. Safety index-Incidence of the adverse reactions

    Incidence of the adverse reactions from day 0 to day 7 after each dose

    Measured: From day 0 to day 7 after each dose

  8. Safety index-Incidence of the adverse reactions

    Incidence of the adverse reactions from day 0 to 28 days after the last dose

    Measured: From day 0 to 28 days after the last dose

  9. Safety index-Incidence of the serious adverse events and the adverse events of special concern

    Incidence of the serious adverse events and the adverse events of special concern from the beginning vaccination to 6 months after the last dose

    Measured: From the beginning vaccination to 6 months after the last dose

Timeline

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

  1. First posted4 Nov 2021
  2. Study start5 Nov 2021
  3. Primary completion5 Dec 2021
  4. Study completion14 Jul 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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05107557
Sponsor's protocol ID
PRO-nCOV-4002-1
Status last verified
Nov 2021
First submitted
2 Nov 2021
Last updated
11 Aug 2022
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 4 study testing Experimental Group in people with COVID-19, run by Sinovac Biotech Co., Ltd at 2 sites 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 3 inclusion and 20 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 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 (time frame: Day 28 after the second dose of COVID-19 vaccine). 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 NCT05107557.

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 11 Aug 2022.

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