Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Group A:SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine (50µg)
Group B:SARS-CoV-2 mRNA Vaccine, Bivalent (100µg)
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age at the time of first dose of vaccine: adults aged 18-59 years (including boundary values), elderly aged >=60 years, no gender limit; 2. Armpit temperature <37.3? on the day of enrollment; 3. Based on the medical history and relevant physical examination and laboratory examination results, the investigator clinically determined that the patient was in good health; 4. Subjects have independent judgment ability, can read, understand and complete vaccination diary cards, and they participate voluntarily and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patient has a history of infection with SARS-CoV-2 and/or SARS virus, or a history of contact with an infected person (who tested positive for nucleic acid) or a suspected infected patient within 30 days prior to screening, or a history of travel abroad within 30 days prior to screening, or positive SARS-CoV-2 nucleic acid test or SARS-CoV-2 IgM or IgG test before the first dose of vaccine; 2. A history of allergy to any component of the investigatory vaccine or a history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylactic shock, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura or local anaphylactic necrosis [Arthus reaction]); 3. Upon inquiry, have a history of COVID-19 vaccination, or have received other inactivated vaccines 14 days before screening, or have received live attenuated vaccines within 28 days; 4. Have a medical history or family history of epilepsy, convulsions or convulsions, neurological diseases and mental diseases; 5. There are contraindications to intramuscular injection, such as diagnosed thrombocytopenia, any clotting disorders, or anticoagulant therapy; 6. Patients with known impairment or low immunological function diagnosed by hospital prior to enrollment, or functional anplenectomy or splenectomy as a result of any condition; 7. Evidence of tobacco, alcohol and drug abusers and those who did not agree to abstain from smoking and drinking during the study period; 8. Laboratory tests (blood routine, urine routine, blood biochemistry, troponin, coagulation routine, D-dimer) and electrocardiogram abnormalities have clinical significance during the screening period; 9. Women: those who have tested positive for pregnancy, are pregnant, are breastfeeding, or plan to become pregnant within one year; Male: whose spouse plans to become pregnant within one year; 10. Patients who participated in other clinical trials (drugs, biologics or devices) within 3 months prior to receiving the first dose of vaccine, or who plan to participate in other clinical trials during the study period; 11. Patients receiving immunoenhanced or immunosuppressive therapy within 6 months prior to the first dose of vaccine (continuous oral or intravenous infusion for more than 14 days); 12. Those who donated blood >=400ml within 28 days prior to screening or received whole blood, plasma and immunoglobulin treatment within 6 months prior to screening; 13. Currently receiving investigational drug therapy for COVID-19 prevention; 14. Patients who were using antipyretic, analgesic and antiallergic drugs within 3 days prior to enrollment; 15. Patients who, in the investigator's judgment, are unable to comply with study procedures, follow protocol, or plan to permanently relocate from the area prior to the end of the study, or plan to leave the area for an extended period of time during the scheduled visit; 16. Relevant staff members participating in the study themselves or their immediate family members (e.g. spouse, parents, siblings or children); 17. According to the investigator, there are other conditions that are not suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Incidence of adverse events associated with the study vaccine ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade >=3 adverse events;Incidence of grade >=3 adverse events associated with the study vaccine;Withdrawal from the study due to adverse events ;Incidence of serious adverse events (SAE) and adverse events of special concern (AESI);Incidence of SAE and AESI associated with the study vaccine;Incidence of clinically significant abnormalities in laboratory measures ; | — |
Countries
China
Contacts
Public ContactZhou Huan / Wu Qiang
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed