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COVID-19Phase 4NCT05398926

Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly

A Phase 4 study testing COVID-19 Vaccine (Vero cell), Inactivated in people with COVID-19, run by Sinovac Life Sciences 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 phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
COVID-19 Vaccine (Vero cell), Inactivated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
6 Dec 2021to 30 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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects aged 60 years and above;
  • Provide legal identification;
  • Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research\& Development Co., Ltd. for 3~6 months（The interval between two doses was 21~35 days）；
  • Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan.

Who cannot join

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research\& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research\& Development Co., Ltd.;
  • History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema;
  • 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;
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  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months or plan to receive these treatments during the study period;
  • Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days,or 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;
  • 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

  • Yongde Center for Diseases Control and Prevention

    Lincang, Yunnan, 677600

Other trials in China

About this study

Official title: An Open Clinical Trial to Evaluate Immunogenicity and Safety of a Third Dose at Different Times After Two-dose of COVID-19 Vaccine (Vero Cell), Inactivated in the Elderly Aged 60 Years and Above

This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.

Read the detailed description

This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.

Conditions
COVID-19
Being tested
COVID-19 Vaccine (Vero cell), 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 (Vero cell), InactivatedBiological

    Also called CoronaVac®

    The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.

Study groups in NCT05398926
Study groupRoleWhat they receive
Experimental group 1 (3-month interval)Experimental100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval）.
Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated
Experimental group 2 (4-month interval)Experimental100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval）.
Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated
Experimental group 3 (5-month interval)Experimental100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval）.
Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated
Experimental group 4 (6-month interval)Experimental100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval）.
Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated

What is being measured

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

  1. Immunogenicity index-GMT of neutralizing antibodies

    GMT of neutralizing antibodies at 14 days after vaccination

    Measured: At 14 days after vaccination

  2. Immunogenicity index- GMT of neutralizing antibodies

    GMT of neutralizing antibodies at 28 days after vaccination

    Measured: At 28 days after vaccination

  3. Safety index-Incidence of adverse reactions

    Incidence of adverse reactions 0~28 days after vaccination

    Measured: 0~28 days after vaccination

Secondary outcomes (5)

  1. Immunogenicity index-seropositive rate of neutralizing antibodies

    Seropositive rate of neutralizing antibodies of neutralizing antibodies before vaccination and at different points after vaccination

    Measured: Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination

  2. Immunogenicity index-GMT of neutralizing antibodies

    GMT of neutralizing antibodies before vaccination and at different points after vaccination.

    Measured: Day 0 before vaccination and 180 days after vaccination

  3. Immunogenicity index-4-fold increase rate of neutralizing antibodies

    4-fold increase rate of neutralizing antibodies at different points after vaccination.

    Measured: At 14 days and 28 days after vaccination.

  4. Safety index-Incidence of adverse reactions

    Incidence of adverse reactions 0~7 days after vaccination.

    Measured: 0~7 days after vaccination

  5. Safety index-Incidence of serious adverse events

    Incidence of serious adverse events 6 months after vaccination.

    Measured: 6 months 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 posted1 Jun 2022
  2. Study start6 Dec 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398926
Sponsor's protocol ID
PRO-nCoV-4011
Status last verified
May 2022
First submitted
31 May 2022
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 COVID-19 Vaccine (Vero cell), Inactivated in people with COVID-19, run by Sinovac Life Sciences 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 13 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 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?

Immunogenicity index-GMT of neutralizing antibodies (time frame: At 14 days after vaccination). The study lists 3 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 NCT05398926.

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.

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