A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned toexperimental group and control group in a 1:1 ratio, with 258 subjects in each sequentialgroup.
Not Provided
Biological: Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-09)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-09) in the
deltoid muscle of the upper arm
Biological: Inactivated COVID-19 vaccine (Vero cells)
Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of
Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Inclusion Criteria:
- Age: population aged 18 years and above;
- Judged by the investigator that the health condition is well after inquiry and
physical examination;
- Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6
months prior to study screening and according to product insert;
- Female participants who are not pregnant or nursing or at the time of enrolment
(confirmed via negative urine pregnancy test), and do not have plans to become
pregnant within the first 6 months after enrollment. Effective contraceptive
measures have been taken within 2 weeks before study inclusion and initiation;
- Be able and willing to provide written informed consent to participate in the study
and complete all study requirements according to the study protocol;
Exclusion Criteria:
- COVID-19 infection positive patients (including suspected or asymptomatic cases);
- Have a history of SARS and MERS infection;
- Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine;
- Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
- Have had previous allergic reactions to vaccination (such as acute allergic
reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or
allergy to known components of COVID-19 vaccine;
- History of thrombocytopenia or other coagulation disorders;
- Patients with known immunological impairment or immunocompromised.
- Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3
months before study enrollment
- Have known or suspected severe illness such as respiratory illness, acute infection
or active attacks of chronic illness, liver and kidney disease, severe diabetes
mellitus, malignant tumour, infectious or allergic skin disease, human
immunodeficiency virus (HIV) infection (test report available);
- Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure,
drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic
blood pressure 95 mmHg).
- Received live attenuated vaccines within 1 month before study enrollment;
- Received inactivated vaccines within 14 days before study enrollment;
- Received other investigational drugs within 6 months before study enrollment;
- Other vaccination-related contraindications considered by investigators.
Sheikh Khalifa Medical City
Seha, Abu Dhab, United Arab Emirates
Not Provided