Novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
Investigation group1:18-59 years old, vaccination with Omicron strain inactivated vaccine
Investigation group1:>=60 years old, vaccination with Omicron strain inactivated vaccine
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age range: populations aged 18 years and above,body mass index BMI: 18-30 (inclusive of the boundary value); 2. Judged by the investigator that the health condition is well after inquiry and physical examination;- 3. Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before inclusion. 4. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan; 5. With self ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.
Exclusion criteria
Exclusion criteria: 1. Confirmed cases, suspected cases or asymptomatic cases of COVID-19; With a history of SARS and MERS infection (self-report, on-site inquiry); 2. SARS-CoV-2 nucleic acid or neutralizing antibody (IgG/IgM) test result is positive; 3. Those who have been vaccinated against the COVID-19 vaccine (including mRNA vaccine, recombinant protein vaccine, protein carrier vaccine, inactivated vaccine, etc.); 4. Axillary Temperature >=37.3 degree; 5. Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite enquiry); 6. Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders(self-report, onsite enquiry); 7. With known immunological impairment or immunocompromised diagnosed by the hospital(self-report, onsite enquiry); 8. Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry); 9. Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry); 10. Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, HIV infection (self-report, onsite enquiry, provide test report if available); 11. With hospital-diagnosed serious cardiovascular diseases [cardiopulmonary failure, drug-uncontrolled hypertension , acute attacks of chronic respiratory illness (self-report, onsite enquiry); 12. Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry); 13. Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry); 14. Participating or planning to participate in other interventional vaccine clinical trials during this study; 15. Other vaccination-related contraindications considered by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT and 4-fold rise rate of anti-omicron neutralizing antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT and 4-fold rise rate of anti-omicron neutralizing antibody;GMTs of anti-omicron neutralizing antibody and the proportions of neutralizing antibody titered >= 1: 16, >= 1: 32 and >= 1: 64;neutralizing antibodies against different variants;The incidence and severity of any adverse reactions/events;Incidence of SAE (Serious Adverse Event) and AESI (Adverse Event of Special Interest); | — |
Countries
China
Contacts
Public ContactRuihua Dong
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed