COVID-19Phase 2NCT04884685

Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents

A Phase 2 study testing SARS-CoV-2 Inactivated Vaccine 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

Who is it for?: Ages 3 to 17 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: SARS-CoV-2 Inactivated Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: 1 siteChina
Study dates: 3 May 2021to 20 Jun 2022
Phase: Phase 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 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

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;

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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;
History of alcohol or drug abuse;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
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;
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 Ⅱb Clinical Trial, to Evaluate the Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 3 to 17 Years.

This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.

Read the detailed description

This study is a randomized, double-blinded, placebo-controlled,phase Ⅱb clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.

Conditions: COVID-19
Being tested: SARS-CoV-2 Inactivated Vaccine, Placebo
Medical subject headings: COVID-19

What participants receive

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

SARS-CoV-2 Inactivated VaccineBiological
Also called CoronaVac
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
PlaceboBiological
aluminium hydroxide solution only

Study groups in NCT04884685
Study group	Role	What they receive
Experimental Group	Experimental	Participant will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28. Receives: Biological: SARS-CoV-2 Inactivated Vaccine
Control Group	Placebo comparator	Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28. Receives: Biological: Placebo

What is being measured

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

Safety index-incidence of adverse reactions
Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.
Measured: Day 0-28 after each dose

Secondary outcomes (2)

Safety index-incidence of adverse reactions
Incidence rate of adverse reactions within 7 days after each dose
Measured: Day 0-7 after each dose vaccination
Safety index-incidence of serious adverse events
Incidence rate of serious adverse events from the beginning of the vaccination to 6 months after the second dose vaccination.
Measured: From the beginning of the vaccination to 6 months after the second dose vaccination

Timeline

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

3 May 202120 Jun 2022

First posted13 May 2021
Study start3 May 2021
Primary completion1 Aug 2021
Study completion20 Jun 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04884685
Sponsor's protocol ID: PRO-nCOV-2001
Status last verified: May 2021
First submitted: 7 May 2021
Last updated: 22 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial, to Evaluate the Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 3 to 17 Years.
ClinicalTrials.gov ID: NCT04884685
Acronym / sponsor ID: PRO-nCOV-2001
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 May 2021 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 20 Jun 2022 (actual)
First posted: 13 May 2021 (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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Experimental Group	Experimental	Biological: SARS-CoV-2 Inactivated VaccineParticipant will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.
Control Group	Placebo comparator	Biological: PlaceboPlacebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28.

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy children and adolescents aged 3-17 years;
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.

Key exclusion criteria (22 listed)

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;

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
SARS-CoV-2 Inactivated VaccineAlso: CoronaVac600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection	Biological	Experimental Group
Placeboaluminium hydroxide solution only	Biological	Control Group

Primary outcome

Safety index-incidence of adverse reactions
Time frame: Day 0-28 after each dose
Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.

2 secondary outcomes

Safety index-incidence of adverse reactions
Time frame: Day 0-7 after each dose vaccination
Safety index-incidence of serious adverse events
Time frame: From the beginning of the vaccination to 6 months after the second dose vaccination

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 22 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.

Yuliang Zhao, Master principal investigator

Hubei 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 2 study testing SARS-CoV-2 Inactivated Vaccine 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 3 inclusion and 22 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 22 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. 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 phase mean?

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). 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 NCT04884685.

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 22 Sep 2023.