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COVID-19Phase 4NCT05112913

Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years

A Phase 4 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2 and Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2 in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency ,immunogenicity and safety of COVID-19 vaccine between the commercialized scale… Read more about this study

Who is it for?
Ages 3 to 17 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2 and Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,520 participants
Where
1 siteChina
Study dates
27 Jul 2021to 25 Dec 2023
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 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy children aged 3-17;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
  • Proven legal identity.

Who cannot join

  • History of SARS-CoV-2 infection;
  • History of receiving COVID-19 vaccine;
  • 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)
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
Show all 19Show fewer
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy,absence of spleen, functional absence of spleen, absence of spleen due to any condition or splenectomy;
  • 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;
  • 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;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Axillary temperature >37.0°C;
  • The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 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

1 site in 1 country.

China1 site

  • Yaliang county Center for Disease Control and Prevention

    Xi’an, Shanxi, 710054

Other trials in China

About this study

Official title: A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac）Between Different Workshops for Prevention of COVID-19 in Healthy Children Aged 3-17 Years

This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency ,immunogenicity and safety of COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.

Read the detailed description

This study is a double-blind, randomized phase Ⅳ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.

Conditions
COVID-19
Being tested
Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3
Medical subject headings
COVID-19

What participants receive

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

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1Biological

    Also called CoronaVac

    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Study groups in NCT05112913
Study groupRoleWhat they receive
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2Experimental360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2Experimental360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2Experimental360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3Experimental360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3Experimental360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3Experimental360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1Active comparator360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1

What is being measured

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

  1. Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2

    Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine

    Measured: 28 days after the full immunization

Secondary outcomes (5)

  1. Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2

    Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine

    Measured: 28 days after the full immunization

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

    Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine

    Measured: 28 days after the full immunization

  3. Seropositivity rate of the neutralizing antibody to live SARS-CoV-2

    Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine

    Measured: 28 days after the full immunization

  4. Incidence of adverse reactions 0-7 days after vaccination

    The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination

    Measured: 0-7 days after vaccination

  5. Incidence of adverse reactions 0-28 days after vaccination

    The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination

    Measured: 0-28 days after vaccination

Timeline

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

  1. First posted9 Nov 2021
  2. Study start27 Jul 2021
  3. Primary completion19 Nov 2021
  4. Study completion25 Dec 2023 (estimated)

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
Double blind
Who is masked
Participant, Investigator
Enrolment
2,520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112913
Sponsor's protocol ID
PRO-nCOV-MA4006-SN
Status last verified
Nov 2023
First submitted
8 Nov 2021
Last updated
7 Nov 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 4 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2, Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2 and Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2 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 3 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 7 Nov 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 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?

Results are not available in the source record.

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?

Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 (time frame: 28 days after the full immunization). 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 NCT05112913.

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 7 Nov 2023.

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