COVID-19Phase 4NCT05198336

Immunogenicity of an Inactivated COVID-19 Vaccine

A Phase 4 study testing Inactivated COVID-19 Vaccine 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 an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old. Read more about this study

Who is it for?: Ages 3 to 11 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Inactivated COVID-19 Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 395 participants
Where: 1 siteChina
Study dates: 8 Jan 2022to 30 Dec 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 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose;
The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);
The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;
Proven legal identity.

Who cannot join

Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);
Have received COVID-19 vaccines from other manufacturers;
The interval between blood collection and the second dose is less than 28 days or more than 42 days;
The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.
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

Rushan City Center for Disease Control and Prevention
Weihai, Shandong, 250014

Other trials in China

About this study

Official title: Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years

Read the detailed description

This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.

Conditions: COVID-19
Being tested: Inactivated COVID-19 Vaccine
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 COVID-19 VaccineBiological
Also called CoronaVac
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Study groups in NCT05198336
Study group	Role	What they receive
Experimental Group of children aged 3-5 years old	Experimental	200 subjects aged 3-5 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose Receives: Biological: Inactivated COVID-19 Vaccine
Experimental Group of children aged 6-11 years old	Experimental	200 subjects aged 6-11 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose Receives: Biological: Inactivated COVID-19 Vaccine

What is being measured

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

Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2
Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine
Measured: Day 28(+14 days) after the second dose of vaccine
Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2
GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine
Measured: Day 28(+14 days) after the second dose of vaccine

Timeline

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

8 Jan 202230 Dec 2022

First posted20 Jan 2022
Study start8 Jan 2022
Primary completion24 Jan 2022
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 395 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05198336
Sponsor's protocol ID: PRO-nCOV-MA4007-SD
Status last verified: Jan 2022
First submitted: 19 Jan 2022
Last updated: 25 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years
ClinicalTrials.gov ID: NCT05198336
Acronym / sponsor ID: PRO-nCOV-MA4007-SD
Conditions: COVID-19
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 395 participants (actual)
Lead sponsor: Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jan 2022 (actual)
Primary completion: 24 Jan 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 20 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental Group of children aged 3-5 years old	Experimental	Biological: Inactivated COVID-19 Vaccine200 subjects aged 3-5 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose
Experimental Group of children aged 6-11 years old	Experimental	Biological: Inactivated COVID-19 Vaccine200 subjects aged 6-11 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose

Who may qualify

Ages: 3 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose;
The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);
The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;
Proven legal identity.

Key exclusion criteria (5 listed)

Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);
Have received COVID-19 vaccines from other manufacturers;
The interval between blood collection and the second dose is less than 28 days or more than 42 days;
The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inactivated COVID-19 VaccineAlso: CoronaVac600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection	Biological	Experimental Group of children aged 3-5 years old, Experimental Group of children aged 6-11 years old

Primary outcome

Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2
Time frame: Day 28(+14 days) after the second dose of vaccine
Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine
Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2
Time frame: Day 28(+14 days) after the second dose of vaccine
GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Qing Xu principal investigator

Shandong Provincial Center for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inactivated COVID-19 Vaccine 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 4 inclusion and 5 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 25 Sep 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?

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-Seropositivity rate of the neutralizing antibody to SARS-CoV-2 (time frame: Day 28(+14 days) after the second dose of 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 NCT05198336.

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 25 Sep 2023.