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A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

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

NCT04863638•China National Biotec Group Company Limited

View on ClinicalTrials.gov

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. And subjects in the same age are randomly assigned to different immunization schedule groups.

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.

Eligibility

Age

3 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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).
+4 more criteria

Locations (1)

Yanjin County Center for Disease Control and Prevention

Xinxiang, Henan, China

Key Dates

Start Date

April 29, 2021

Primary Completion Date

December 20, 2021

Completion Date

March 31, 2024

Last Updated

June 18, 2023

Enrollment

4,400

ACTUAL participants

Conditions

Covid19

Interventions

3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

BIOLOGICAL

3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

BIOLOGICAL

3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

BIOLOGICAL

2 doses of vaccine

BIOLOGICAL

The Effect of the Covid-19 Pandemic Among Operated Patients

NCT04525716

Covid19Surgery

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RECRUITINGPHASE3

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

NCT03188796

Critical IllnessVitamin D Deficiency+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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