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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: 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

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 Type: Interventional
• Enrollment (Actual): 4400
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1 aged ≥ 71; 300 subjects age ≥ 71 （A1）receive 3 doses of vaccine	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 42
Experimental: A2 aged ≥ 71; 200 subjects age ≥ 71 （A2）receive 3 doses of vaccine	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 111
Experimental: A3 aged ≥ 71; 200 subjects age ≥ 71 (A3) receive 3 doses of vaccine	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 171
Experimental: B1 aged 60-70; 300 subjects age 60-70 (B1) receive 3 doses of vaccine	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 42
Experimental: B2 aged 60-70; 200 subjects age 60-70 (B2) receive 3 doses of vaccine	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 111
Experimental: B3 aged 60-70; 200 subjects age 60-70 (B3) receive 3 doses of vaccine	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 171
Experimental: C1 aged 18-59; 300 subjects age 18-59 (C1) receive 3 doses of vaccine	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 42
Experimental: C2 aged 18-59; 200 subjects age 18-59 (C2) receive 3 doses of vaccine	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 111
Experimental: C3 aged 18-59; 200 subjects age 18-59 (C3) receive 3 doses of vaccine	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 171
Experimental: C4 aged 18-59; 300 subjects age 18-59 (C4) receive 2 doses of vaccine	Biological: 2 doses of vaccine; the schedule of Day 0, 21
Experimental: D1 aged 9-17; 300 subjects age 9-17 (D1) receive 3 doses of vaccine	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 42
Experimental: D2 aged 9-17; 200 subjects age 9-17 (D2) receive 3 doses of vaccine	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 111
Experimental: D3 aged 9-17; 200 subjects age 9-17 （D3）receive 3 doses of vaccine	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 171
Experimental: D4 aged 9-17; 300 subjects age 9-17 （D4）receive 2 doses of vaccine	Biological: 2 doses of vaccine; the schedule of Day 0, 21
Experimental: E1 aged 3-8; 300 subjects age 3-8 （E1） receive 3 doses of vaccine	Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 42
Experimental: E2 aged 3-8; 200 subjects age 3-8 （E2）receive 3 doses of vaccine	Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 111
Experimental: E3 aged 3-8; 200 subjects age 3-8 （E3）receive 3 doses of vaccine	Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated; the schedule of Day 0, 21, 171
Experimental: E4 aged 3-8; 300 subjects age 3-8 （E4）receive 2 doses of vaccine	Biological: 2 doses of vaccine; the schedule of Day 0, 21

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Immune Persistence	Neutralizing antibody assay will be performed using the Microcytopathic assay	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	From the beginning of the vaccination to 28 days after the full course immunization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune Persistence	Neutralizing antibody assay will be performed using the Microcytopathic assay	18 months and 24 months after the full immunization

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.
• Investigators: Principal Investigator: Yanxia Wang, Bachelor, Henan Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; SARS-CoV-2 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BIBP2020004CN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No