Covid19Phase 4COVID-19NCT04863638

A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated

A Phase 4 study testing 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated, 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated and 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated in people with Covid19, run by China National Biotec Group Company Limited at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules compared to that in population aged 18-59 years old with 2-dose schedule. Read more about this study

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated, 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated and 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,400 participants
Where: 1 siteChina
Study dates: 29 Apr 2021to 31 Mar 2024
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 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Aged 3 years and above (after enrolled, subjects will be allocated according to age).
By asking for medical history and physical examination, the health condition judged by the investigators is well.
Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
No vaccination history of COVID-19 vaccine before enrollment.
Be able and willing to complete the whole prescribed study plan.
With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

Who cannot join

Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
Has a history of SARS, MERS infection (self-report, on-site inquiry).
>14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.

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Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
Received blood products within 3 months before enrolment.
Received other research drugs within 6 months before enrolment.
Other circumstances judged by investigators are not suitable for this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, 453200

Other trials in China

About this study

Official title: A Immunobridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated in Population Aged ≥ 60 Years Old and 3-17 Years Old Compared With That in Population Aged 18-59 Years Old

Read the detailed description

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.

Conditions: Covid19
Being tested: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated, 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated, 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated, 2 doses of vaccine
Keywords: SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

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

3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), InactivatedBiological
the schedule of Day 0, 21, 42
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), InactivatedBiological
the schedule of Day 0, 21, 111
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), InactivatedBiological
the schedule of Day 0, 21, 171
2 doses of vaccineBiological
the schedule of Day 0, 21

Study groups in NCT04863638
Study group	Role	What they receive
A1 aged ≥ 71	Experimental	300 subjects age ≥ 71 （A1）receive 3 doses of vaccine Receives: Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
A2 aged ≥ 71	Experimental	200 subjects age ≥ 71 （A2）receive 3 doses of vaccine Receives: Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
A3 aged ≥ 71	Experimental	200 subjects age ≥ 71 (A3) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
B1 aged 60-70	Experimental	300 subjects age 60-70 (B1) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
B2 aged 60-70	Experimental	200 subjects age 60-70 (B2) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
B3 aged 60-70	Experimental	200 subjects age 60-70 (B3) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
C1 aged 18-59	Experimental	300 subjects age 18-59 (C1) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
C2 aged 18-59	Experimental	200 subjects age 18-59 (C2) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
C3 aged 18-59	Experimental	200 subjects age 18-59 (C3) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
C4 aged 18-59	Experimental	300 subjects age 18-59 (C4) receive 2 doses of vaccine Receives: Biological: 2 doses of vaccine
D1 aged 9-17	Experimental	300 subjects age 9-17 (D1) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
D2 aged 9-17	Experimental	200 subjects age 9-17 (D2) receive 3 doses of vaccine Receives: Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
D3 aged 9-17	Experimental	200 subjects age 9-17 （D3）receive 3 doses of vaccine Receives: Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
D4 aged 9-17	Experimental	300 subjects age 9-17 （D4）receive 2 doses of vaccine Receives: Biological: 2 doses of vaccine
E1 aged 3-8	Experimental	300 subjects age 3-8 （E1） receive 3 doses of vaccine Receives: Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
E2 aged 3-8	Experimental	200 subjects age 3-8 （E2）receive 3 doses of vaccine Receives: Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
E3 aged 3-8	Experimental	200 subjects age 3-8 （E3）receive 3 doses of vaccine Receives: Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
E4 aged 3-8	Experimental	300 subjects age 3-8 （E4）receive 2 doses of vaccine Receives: Biological: 2 doses of vaccine

What is being measured

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

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Measured: 14 days after the full course immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Measured: 14 days after the full course immunization

Secondary outcomes (7)

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Measured: 14 days after the second dose in schedule of Day 0,21,42
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Measured: 14 days after the second dose in schedule of Day 0,21,42
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Measured: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Measured: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Immune Persistence
Neutralizing antibody assay will be performed using the Microcytopathic assay
Measured: 3 months, 6 months, 12 months after the full course immunization
Safety index-Incidence of adverse reactions
collect the all the adverse events using dairy card and contact card
Measured: From the beginning of the vaccination to 28 days after the full course immunization
Safety index-Incidence of serious adverse events
All SAEs will be collected
Measured: From the beginning of the vaccination to 6 months after the full course immunization

Timeline

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

29 Apr 202131 Mar 2024

First posted28 Apr 2021
Study start29 Apr 2021
Primary completion20 Dec 2021
Study completion31 Mar 2024 (estimated)

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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4,400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04863638
Sponsor's protocol ID: BIBP2020004CN
Acronym: COVID-19
Status last verified: Jun 2023
First submitted: 27 Apr 2021
Last updated: 18 Jun 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Immunobridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated in Population Aged ≥ 60 Years Old and 3-17 Years Old Compared With That in Population Aged 18-59 Years Old
ClinicalTrials.gov ID: NCT04863638
Acronym / sponsor ID: COVID-19 / BIBP2020004CN
Conditions: Covid19
Keywords: SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4,400 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Beijing Institute of Biological Products Co Ltd.
Study start: 29 Apr 2021 (actual)
Primary completion: 20 Dec 2021 (actual)
Study completion: 31 Mar 2024 (estimated)
First posted: 28 Apr 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

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 18

Arm	Type	Receives
A1 aged ≥ 71	Experimental	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated300 subjects age ≥ 71 （A1）receive 3 doses of vaccine
A2 aged ≥ 71	Experimental	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age ≥ 71 （A2）receive 3 doses of vaccine
A3 aged ≥ 71	Experimental	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
B1 aged 60-70	Experimental	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated300 subjects age 60-70 (B1) receive 3 doses of vaccine
B2 aged 60-70	Experimental	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 60-70 (B2) receive 3 doses of vaccine
B3 aged 60-70	Experimental	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 60-70 (B3) receive 3 doses of vaccine
C1 aged 18-59	Experimental	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated300 subjects age 18-59 (C1) receive 3 doses of vaccine
C2 aged 18-59	Experimental	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 18-59 (C2) receive 3 doses of vaccine
C3 aged 18-59	Experimental	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 18-59 (C3) receive 3 doses of vaccine
C4 aged 18-59	Experimental	Biological: 2 doses of vaccine300 subjects age 18-59 (C4) receive 2 doses of vaccine
D1 aged 9-17	Experimental	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated300 subjects age 9-17 (D1) receive 3 doses of vaccine
D2 aged 9-17	Experimental	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 9-17 (D2) receive 3 doses of vaccine
D3 aged 9-17	Experimental	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 9-17 （D3）receive 3 doses of vaccine
D4 aged 9-17	Experimental	Biological: 2 doses of vaccine300 subjects age 9-17 （D4）receive 2 doses of vaccine
E1 aged 3-8	Experimental	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated300 subjects age 3-8 （E1） receive 3 doses of vaccine
E2 aged 3-8	Experimental	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 3-8 （E2）receive 3 doses of vaccine
E3 aged 3-8	Experimental	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated200 subjects age 3-8 （E3）receive 3 doses of vaccine
E4 aged 3-8	Experimental	Biological: 2 doses of vaccine300 subjects age 3-8 （E4）receive 2 doses of vaccine

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Aged 3 years and above (after enrolled, subjects will be allocated according to age).
By asking for medical history and physical examination, the health condition judged by the investigators is well.
Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
No vaccination history of COVID-19 vaccine before enrollment.
Be able and willing to complete the whole prescribed study plan.

Key exclusion criteria (14 listed)

Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
Has a history of SARS, MERS infection (self-report, on-site inquiry).
>14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.

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
3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivatedthe schedule of Day 0, 21, 42	Biological	A1 aged ≥ 71, B1 aged 60-70, C1 aged 18-59, D1 aged 9-17, E1 aged 3-8
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivatedthe schedule of Day 0, 21, 111	Biological	A2 aged ≥ 71, B2 aged 60-70, C2 aged 18-59, D2 aged 9-17, E2 aged 3-8
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivatedthe schedule of Day 0, 21, 171	Biological	A3 aged ≥ 71, B3 aged 60-70, C3 aged 18-59, D3 aged 9-17, E3 aged 3-8
2 doses of vaccinethe schedule of Day 0, 21	Biological	C4 aged 18-59, D4 aged 9-17, E4 aged 3-8

Primary outcome

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after the full course immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after the full course immunization
≥4 fold increase from baseline

7 secondary outcomes

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after the second dose in schedule of Day 0,21,42
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after the second dose in schedule of Day 0,21,42
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Immune Persistence
Time frame: 3 months, 6 months, 12 months after the full course immunization
Safety index-Incidence of adverse reactions
Time frame: From the beginning of the vaccination to 28 days after the full course immunization
Safety index-Incidence of serious adverse events
Time frame: From the beginning of the vaccination to 6 months after the full course immunization

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.

Yanxia Wang, Bachelor principal investigator

Henan 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?

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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Jun 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?

Results are not available in the source record.

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?

The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody (time frame: 14 days after the full course immunization). 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 NCT04863638.

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 18 Jun 2023.