AzTrials
AzTrials

COVID-19Phase 4NCT04894227

Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

A Phase 4 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell） 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
Search all trials

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 CoronaVac in healthy adults aged 26-45 years. Read more about this study

Who is it for?
Ages 26 to 45 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Inactivated SARS-CoV-2 Vaccine (Vero cell）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,080 participants
Where
1 siteChina
Study dates
11 May 2021to 30 Nov 2021
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 26 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 26-45;
  • The subjects can understand and voluntarily sign the informed consent form ;
  • Proven legal identity.

Who cannot join

  • Travel history / residence history of communities with case reports within 14 days prior to the study;
  • History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days prior to the study;
  • Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days prior to the study;
  • Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days prior to the study;
  • History of SARS-CoV-2 infection or 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;
Show all 23Show fewer
  • 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.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness 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 alcohol or 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;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months;
  • 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

1 site in 1 country.

China1 site

  • Jingliang Wu

    Huai'an, Jiangsu, 223300

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） in Health Adults Aged 26-45 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 CoronaVac in healthy adults aged 26-45 years.

Read the detailed description

This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.

Conditions
COVID-19
Being tested
Inactivated SARS-CoV-2 Vaccine (Vero cell）
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）Biological

    Also called CoronaVac

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

Study groups in NCT04894227
Study groupRoleWhat they receive
Inactivated SARS-CoV-2 vaccine Lot 1ExperimentalParticipants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）
Inactivated SARS-CoV-2 vaccine Lot 2ExperimentalParticipants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）
Inactivated SARS-CoV-2 vaccine Lot 3ExperimentalParticipants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）

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 in susceptible population

    GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

    Measured: Day 28 after the second dose

Secondary outcomes (12)

  1. Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population

    Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

    Measured: Day 28 after the second dose

  2. Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population

    Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

    Measured: Day 28 after the second dose

  3. GMT of the neutralizing antibody to live SARS-CoV-2 in total population

    GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

    Measured: Day 28 after the second dose

  4. Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population

    GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

    Measured: Day 28 after the second dose

  5. Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population

    Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

    Measured: Day 28 after the second dose

  6. Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population

    Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

    Measured: Day 28 after the second dose

  7. GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population

    GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

    Measured: Day 28 after the second dose

  8. Seropositivity rate of anti-SARS-CoV-2 S antibody

    Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

    Measured: Day 28 after the second dose

  9. Seroconversion rate of anti-SARS-CoV-2 S antibody

    Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

    Measured: Day 28 after the second dose

  10. Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody

    GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

    Measured: Day 28 after the second dose

  11. GMI of anti-SARS-CoV-2 S antibody

    GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

    Measured: Day 28 after the second dose

  12. Incidence of adverse reactions after vaccination

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

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

Timeline

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

  1. First posted20 May 2021
  2. Study start11 May 2021
  3. Primary completion11 May 2021
  4. Study completion30 Nov 2021

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
1,080 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894227
Sponsor's protocol ID
PRO-nCOV-4001
Status last verified
May 2021
First submitted
10 May 2021
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhu D, Hu Y, Jiang Z, Yang T, Chu K, Zhang H, Hu J, Meng X, Tan Z, Wu J, Lian X, Li C, Pan H. Lot-to-lot consistency, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults: A randomized, double-blind, phase IV trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2135929. doi: 10.1080/21645515.2022.2135929. Epub 2022 Nov 28.

    PubMed 36441137

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell） 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 23 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 13 Apr 2022. 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?

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?

Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population (time frame: Day 28 after the second dose). 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 NCT04894227, which also lists 1 linked publication.

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 13 Apr 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