Covid19Phase 3NCT04617483

Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults

A Phase 3 study testing Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14, Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 and Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly in people with Covid19, 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14, Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 and Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,040 participants
Where: 1 siteChina
Study dates: 31 Oct 2020to 31 May 2021
Phase: Phase 3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults aged 18-59 or elderly aged ≥60 years;
Proven legal identity.

Who cannot join

Travel/residence history of communities with reported cases within 14 days before trial;
History of exposure to Novel Coronavirus infection (nucleic acid positive) within 14 days prior to the trial;
Exposed to patients with fever or respiratory symptoms from communities with reported cases within 14 days prior to the trial;
Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial;
History of SARS-CoV-2 infection;
History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;

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Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency/immunosuppression;
Patients with serious chronic diseases, serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.;
Serious neurological disorder (epilepsy, convulsions or convulsions) or psychosis;
History of thyroid disease or thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy caused by any circumstance;
Coagulation dysfunction (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
Long history of alcohol or drug abuse;
Received blood products within 3 months prior to receiving the vaccine;
Received other research drugs within 30 days prior to receiving the vaccine;
Received live attenuated vaccine within 14 days prior to receiving the vaccine;
Received subunit or inactivated vaccine within 7 days prior to receiving the vaccine;
Onset of various acute or chronic diseases within 7 days prior to the study;
Axillary temperature of >37.0℃ before inoculation of the vaccine;
Those who are already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to become pregnant within 2 months;
In the opinion of the investigator, the participants had any other factors that made them unsuitable to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Dafeng District Center for Disease Prevention and Control
Yancheng, Jiangsu, 224100

Other trials in China

About this study

Official title: A Randomized, Double-Blinded Clinical Trial, to Evaluate the Non-inferiority of the Commercial Scale Inactivated SARS-CoV-2 Vaccine Against That of the Pilot Scale Among Adults Aged 26-45 Years, and the Open-labelled, Bridging Non-inferiority of the Vaccine Induced Immunogenicity in Elderly Against That in Adults

Read the detailed description

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. Totally 1040 subjects，including: 130 subjects aged 18~25 years; 520 subjects aged 26~45 years, with 260 in each group; 130 subjects aged 46~59 years; 260 subjects aged ≥60 years.

Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.

Conditions: Covid19
Being tested: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14, Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14, Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly
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 commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14Biological
The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.
Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14Biological
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.
Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderlyBiological
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.

Study groups in NCT04617483
Study group	Role	What they receive
Aged 26-45, Commercial Scale	Experimental	Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years. Receives: Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
Aged 18-59, Pilot Scale	Experimental	Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years. Receives: Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
Aged ≥60, Pilot Scale	Experimental	Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years. Receives: Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly

What is being measured

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

Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method
Measured: Day 14 after the full course vaccination

Secondary outcomes (4)

Immunogenicity index-Seroconversion rate of the 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: Day 14 after the full course vaccination
Immunogenicity index-Seropositive rate of the neutralizing antibody
Neutralizing antibody assay will be performed using the micro-neutralization method. Subjects with a antibody titer ≥1:8 will defined as seropositive
Measured: Day 14 after the full course vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions from the beginning of the vaccination to 28 days after the full course vaccination
Measured: From the beginning of the vaccination to 28 days after the full course vaccination
Safety index-Incidence of serious adverse events
SAE will be collected throughout the clinical trial
Measured: From the beginning of the vaccination to 6 months after the full course vaccination

Timeline

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

31 Oct 202031 May 2021

First posted5 Nov 2020
Study start31 Oct 2020
Primary completion28 Nov 2020
Study completion31 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,040 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04617483
Sponsor's protocol ID: PRO-nCOV-3001
Status last verified: Nov 2020
First submitted: 4 Nov 2020
Last updated: 27 Jul 2021
Results posted: No
Data monitoring committee: Yes
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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded Clinical Trial, to Evaluate the Non-inferiority of the Commercial Scale Inactivated SARS-CoV-2 Vaccine Against That of the Pilot Scale Among Adults Aged 26-45 Years, and the Open-labelled, Bridging Non-inferiority of the Vaccine Induced Immunogenicity in Elderly Against That in Adults
ClinicalTrials.gov ID: NCT04617483
Acronym / sponsor ID: PRO-nCOV-3001
Conditions: Covid19
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,040 participants (actual)
Lead sponsor: Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
Study start: 31 Oct 2020 (actual)
Primary completion: 28 Nov 2020 (actual)
Study completion: 31 May 2021 (actual)
First posted: 5 Nov 2020 (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

Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Aged 26-45, Commercial Scale	Experimental	Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years.
Aged 18-59, Pilot Scale	Experimental	Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years.
Aged ≥60, Pilot Scale	Experimental	Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderlyPilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy adults aged 18-59 or elderly aged ≥60 years;
Proven legal identity.

Key exclusion criteria (22 listed)

Travel/residence history of communities with reported cases within 14 days before trial;
History of exposure to Novel Coronavirus infection (nucleic acid positive) within 14 days prior to the trial;
Exposed to patients with fever or respiratory symptoms from communities with reported cases within 14 days prior to the trial;
Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial;
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
Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.	Biological	Aged 26-45, Commercial Scale
Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.	Biological	Aged 18-59, Pilot Scale
Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderlyThe antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.	Biological	Aged ≥60, Pilot Scale

Primary outcome

Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
Time frame: Day 14 after the full course vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method

4 secondary outcomes

Immunogenicity index-Seroconversion rate of the neutralizing antibody
Time frame: Day 14 after the full course vaccination
Immunogenicity index-Seropositive rate of the neutralizing antibody
Time frame: Day 14 after the full course vaccination
Safety index-Incidence of adverse reactions
Time frame: From the beginning of the vaccination to 28 days after the full course vaccination
Safety index-Incidence of serious adverse events
Time frame: From the beginning of the vaccination to 6 months after the full course 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 27 Jul 2021.

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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.

Hongxing Pan, Master principal investigator

Jiangsu Provincial Center for Disease Prevention and Control

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

Questions about this trial

What is this clinical trial studying?

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 2 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 27 Jul 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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-geometric mean titer(GMT) of neutralizing antibody (time frame: Day 14 after the full course vaccination). 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 NCT04617483.

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 27 Jul 2021.