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

Covid19 Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04863638
• Other study ID #: BIBP2020004CN
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 29, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4400
• Est. completion date: March 31, 2024
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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).
• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
• 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
• 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
• 2 doses of vaccine
the schedule of Day 0, 21

Locations

Country	Name	City	State
China	Yanjin County Center for Disease Control and Prevention	Xinxiang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune Persistence	Neutralizing antibody assay will be performed using the Microcytopathic assay	18 months and 24 months after the full immunization
Primary	The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody	Neutralizing antibody assay will be performed using the Microcytopathic assay	14 days after the full course immunization
Primary	The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody	=4 fold increase from baseline	14 days after the full course immunization
Secondary	The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody	Neutralizing antibody assay will be performed using the Microcytopathic assay	14 days after the second dose in schedule of Day 0,21,42
Secondary	The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody	=4 fold increase from baseline	14 days after the second dose in schedule of Day 0,21,42
Secondary	The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody	Neutralizing antibody assay will be performed using the Microcytopathic assay	before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Secondary	The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody	=4 fold increase from baseline	before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Secondary	Immune Persistence	Neutralizing antibody assay will be performed using the Microcytopathic assay	3 months, 6 months, 12 months after the full course immunization
Secondary	Safety index-Incidence of adverse reactions	collect the all the adverse events using dairy card and contact card	From the beginning of the vaccination to 28 days after the full course immunization
Secondary	Safety index-Incidence of serious adverse events	All SAEs will be collected	From the beginning of the vaccination to 6 months after the full course immunization