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COVID-19Phase 1/2NCT04551547

Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19

A Phase 1/2 study testing Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 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 study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. 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?
Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
552 participants
Where
1 siteChina
Study dates
31 Oct 2020to 8 Feb 2023
Phase
Phase 1/2
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 and adolescents aged 3-17 years;
  • The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old);
  • Proven legal identity.

Who cannot join

  • Travel history / residence history of communities with case reports within 14 days;
  • History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
  • Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
  • 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;
  • History of SARS-CoV-2 infection;
  • 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 26Show fewer
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • 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;
  • Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase I clinical trials):
  • Blood routine test: white blood cell count, hemoglobin, platelet count;
  • Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;
  • Urine routine index: urine protein (PRO);
  • 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;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant 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

  • Zanhuang county Center for Disease Control and Prevention

    Shijiazhuang, Hebei, 051230

Other trials in China

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years

This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years

Read the detailed description

This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.

Conditions
COVID-19
Being tested
Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of placebo at the schedule of day 0,28
Medical subject headings
COVID-19

What participants receive

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

  • Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28Biological

    The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml

  • Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28Biological

    The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml

  • Two doses of placebo at the schedule of day 0,28Other

    The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd.

Study groups in NCT04551547
Study groupRoleWhat they receive
Experimental Vaccine-low dosageExperimentallow dosage inactivated SARS-CoV-2 vaccine
Receives: Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Experimental Vaccine-medium dosageExperimentalmedium dosage inactivated SARS-CoV-2 vaccine
Receives: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
PlaceboPlacebo comparatorNo active ingredient in the placebo
Receives: Other: Two doses of placebo at the schedule of day 0,28

What is being measured

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

  1. Safety index-incidence of adverse reactions

    Incidence of adverse reactions after each dose vaccination.

    Measured: Day 0-28 after each dose vaccination

  2. Immunogenicity index-seroconversion rates of neutralizing antibody

    Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.

    Measured: The 28th day after the second dose vaccination

Secondary outcomes (12)

  1. Safety index-incidence of serious adverse events

    SAE will be collected throughout the clinical trial.

    Measured: From the beginning of the vaccination to 12 months after the second dose vaccination

  2. Immunogenicity index-seropositive rates of neutralizing antibody

    Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.

    Measured: The 28th day after each dose vaccination and the 12 month after the second dose vaccination

  3. Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody

    Neutralizing antibody assay will be performed using the micro-neutralization method.

    Measured: The 28th day after each dose vaccination and the 12 month after the second dose vaccination

  4. Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody

    Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.

    Measured: The 28th day after each dose vaccination and the 12 month after the second dose vaccination

  5. Safety index-Incidence rate of adverse reactions

    Incidence rate of adverse reactions within 7 days after each dose vaccination

    Measured: Within 7 days after each dose vaccination

  6. Safety index-Incidence of abnormal laboratory index

    Incidence of abnormal laboratory index (blood routine test, blood chemistry test, and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ

    Measured: On the 3th day after each dose of vaccination in phase Ⅰ

  7. Safety index-Incidence rate of AESIs

    Incidence rate of SAEs and AESIs from the beginning of the vaccination to 12 months after the last dose vaccination

    Measured: From the beginning of the vaccination to 12 months after the last dose vaccination

  8. Immunogenicity index- GMI of neutralizing antibody

    GMI of neutralizing antibodies 28 days after the second dose vaccination

    Measured: 28 days after the second dose vaccination

  9. Immunogenicity index-the seroconversion rate

    The seroconversion rate 28 days after the first dose vaccination in phase Ⅰ

    Measured: 28 days after the first dose vaccination in phase Ⅰ

  10. Immunogenicity index-the seropositive rate

    Seropositive rate 28 days after the first dose vaccination in phase Ⅰ

    Measured: 28 days after the first dose vaccination in phase Ⅰ

  11. Immunogenicity index-the GMT

    The GMT 28 days after the first dose vaccination in phase Ⅰ

    Measured: 28 days after the first dose vaccination in phase Ⅰ

  12. Immunogenicity index-the GMI

    The GMI 28 days after the first dose vaccination in phase Ⅰ

    Measured: 28 days after the first dose vaccination in phase Ⅰ

Timeline

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

  1. First posted16 Sep 2020
  2. Study start31 Oct 2020
  3. Primary completion30 Apr 2021
  4. Study completion8 Feb 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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551547
Sponsor's protocol ID
PRO-nCOV-1003
Status last verified
Jun 2021
First submitted
15 Sep 2020
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, Li M, Lian X, Jiao W, Wang L, Shu Q, Wu Z, Zhao Y, Li Q, Gao Q. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1645-1653. doi: 10.1016/S1473-3099(21)00319-4. Epub 2021 Jun 28.

    PubMed 34197764

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 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 26 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 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Safety index-incidence of adverse reactions (time frame: Day 0-28 after each dose vaccination). 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 NCT04551547, 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 2 Oct 2023.

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