A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated
Phase 4
Active, not recruiting
- Conditions
- Covid19
- Interventions
- Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), InactivatedBiological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), InactivatedBiological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), InactivatedBiological: 2 doses of vaccine
- Registration Number
- NCT04863638
- Lead Sponsor
- China National Biotec Group Company Limited
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4400
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C3 aged 18-59 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 18-59 (C3) receive 3 doses of vaccine C1 aged 18-59 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated 300 subjects age 18-59 (C1) receive 3 doses of vaccine C2 aged 18-59 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 18-59 (C2) receive 3 doses of vaccine B3 aged 60-70 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 60-70 (B3) receive 3 doses of vaccine A2 aged ≥ 71 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age ≥ 71 （A2）receive 3 doses of vaccine A3 aged ≥ 71 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age ≥ 71 (A3) receive 3 doses of vaccine B1 aged 60-70 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated 300 subjects age 60-70 (B1) receive 3 doses of vaccine A1 aged ≥ 71 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated 300 subjects age ≥ 71 （A1）receive 3 doses of vaccine D1 aged 9-17 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated 300 subjects age 9-17 (D1) receive 3 doses of vaccine D2 aged 9-17 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 9-17 (D2) receive 3 doses of vaccine B2 aged 60-70 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 60-70 (B2) receive 3 doses of vaccine C4 aged 18-59 2 doses of vaccine 300 subjects age 18-59 (C4) receive 2 doses of vaccine E2 aged 3-8 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 3-8 （E2）receive 3 doses of vaccine E3 aged 3-8 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 3-8 （E3）receive 3 doses of vaccine D4 aged 9-17 2 doses of vaccine 300 subjects age 9-17 （D4）receive 2 doses of vaccine E4 aged 3-8 2 doses of vaccine 300 subjects age 3-8 （E4）receive 2 doses of vaccine D3 aged 9-17 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated 200 subjects age 9-17 （D3）receive 3 doses of vaccine E1 aged 3-8 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated 300 subjects age 3-8 （E1） receive 3 doses of vaccine
- Primary Outcome Measures
Name Time Method The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody 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 14 days after the full course immunization ≥4 fold increase from baseline
- Secondary Outcome Measures
Name Time Method Safety index-Incidence of serious adverse events From the beginning of the vaccination to 6 months after the full course immunization All SAEs will be collected
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody before the third dose in schedules of Day 0,21,111 and Day 0,21,171 Neutralizing antibody assay will be performed using the Microcytopathic assay
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody before the third dose in schedules of Day 0,21,111 and Day 0,21,171 ≥4 fold increase from baseline
Immune Persistence 3 months, 6 months, 12 months after the full course immunization Neutralizing antibody assay will be performed using the Microcytopathic assay
Safety index-Incidence of adverse reactions From the beginning of the vaccination to 28 days after the full course immunization collect the all the adverse events using dairy card and contact card
Trial Locations
- Locations (1)
Yanjin County Center for Disease Control and Prevention
🇨🇳Xinxiang, Henan, China