This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (VeroCell), Inactivated and in population aged 60 years old and 3-17 years old with differentschedules compared to that in population aged 18-59 years old with 2-dose schedule. Andsubjects in the same age are randomly assigned to different immunization schedule groups.
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.
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171
Biological: 2 doses of vaccine
the schedule of Day 0, 21
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.
Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, China
Yanxia Wang, Bachelor, Principal Investigator
Henan Provincial Center for Disease Control and Prevention