Prevention of COVID-19 Pneumonia and Influenza
Conditions
Interventions
Test group 1:WSK-V102EFa
Test group 2:WSK-V102EFb
Control group1:Influenza Vaccine
Control group2:WSK-V102E
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Be aged 18 years and above on the day of enrollment and be able to provide valid identification of the subject himself/herself; 2.Able to comply with the requirements of the clinical research protocol to complete all trial procedures, able to understand the content of informed consent and voluntarily sign the informed consent form; 3.Completion of basic or booster immunization with Neocoronavirus vaccine for >=3 months, and no history of Neocoronavirus infection within 3 months, or have never been infected with Neocoronavirus; 4.Men of childbearing potential and women of childbearing age voluntarily use effective contraception, including abstinence or effective contraception (e.g), intrauterine or implantable contraceptive devices, oral contraceptives, injectable or buried contraceptives, extended-release local contraceptives, intrauterine devices (IUDs), condoms (for males), diaphragms, cervical caps, etc.), starting from the time of signing the informed consent form and up to 3 months after completion of vaccination.
Exclusion criteria
Exclusion criteria: 1. Axillary body temperature >=37.3°C; 2.Positive SARS-CoV-2 antigen and influenza antigen test at screening; 3.Influenza patients, or those who have been infected with influenza within 3 months (confirmed by clinical questioning.; 4.Having received influenza test vaccine or other influenza vaccine 3 months prior to enrollment; 5.Suffering from congenital anomalies or hereditary diseases (Down syndrome, moderate to severe thalassemia, congenital heart disease), acute or chronic infectious diseases (tuberculosis, various types of viral hepatitis, etc.. that may interfere with the conduct or completion of the test; 6.Oncological diseases or any malignant blood diseases (except localized skin cancer or prostate cancer that is in a stable stage and not under treatment at the time of vaccination, and except for subjects with a history of oncological diseases and who have survived disease-free for more than 5 years); 7.Subjects with a history of severe allergic disease, history of spasticity, or history of severe adverse reaction to the vaccine (e.g., urticaria, eczema of the skin, respiratory distress, angioneurotic edema, or abdominal pain), or who are allergic to any of the components of the medication used in the test; 8. Suffering from a serious medical condition that may interfere with the conduct or completion of the test (including: interstitial pneumonitis, bronchial asthma, chronic bronchitis during an exacerbation, heart disease, renal disease, liver disease, diabetes mellitus (unstable control of blood glucose or inability to control blood glucose with medication, or complications of diabetes mellitus), endocrine disorders such as hyperthyroidism, hereditary allergies, severe nutritional deficiencies, severe developmental disorders, infectious /allergic skin diseases, etc.); 9.Autoimmune disease or immunodeficiency, systemic chemotherapy within the last 5 years, have received or plan to use systemic medications including immunosuppressive and/or immunomodulatory agents, any blood products, leukocytotoxic treatments for a prolonged period of time during the study period within the last 6 months (more than 14 consecutive days); 10.Has been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune disease; 11.Thrombocytopenia or bleeding disorders that, in the judgment of the investigator, may not contraindicate intramuscular vaccination; 12. Asthma, unstable for the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; 13.History or family history of psychiatric and neurologic conditions such as convulsions, epilepsy, encephalopathy and psychosis; 14.Absence of spleen, functional absence of spleen, and any condition resulting in absence of spleen or splenectomy; 15.Severe neurologic disorders such as Guillain-Barre syndrome; 16.Those who have received, or plan to use, blood products or immunoglobulin products during the study within 3 months prior to receiving the experimental drug; 17.who have received a live attenuated vaccine within 28 days and a subunit or inactivated vaccine within 14 days prior to receiving the experimental vaccine; 18. Significant mental illness and/or drug or alcohol abuse that, in the opinion of the investigator, would compromise subject safety and/or compliance with study procedures; 19.Participation, or planned participation, in another clinical study of a vaccine, drug, medical device, or medi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reaction (AR) within 7 days of vaccination;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE) within 7 days of vaccination;;Incidence of adverse events/adverse reactions within 28 days of vaccination;; Incidence of serious adverse events (SAEs) within 6 months of vaccination.;Geometric mean titer (GMT), positive conversion rate, and geometric mean multiplicity of increase (GMI) of neutralizing antibodies specific to the anti-SARS-COV-2 variant (the predominantly prevalent strain at that time) before vaccination, on days 14 and 28 after vaccination in all subjects (live virus or pseudovirus neutralization test);;The geometric mean titer (GMT), positive conversion rate and geometric mean multiplicity of increase (GMI) of antibodies against the four strains of hemagglutination inhibition (HI) in all subjects before vaccination, on the 14th and 28th day after vaccination;;Geometric mean titer (GMT), positive conversion rate, and geometric mean multiplicity of increase (GMI) of anti-SARS-COV-2 S-RBD IgG antibodies before, 14 days after, and on day 28 of vaccination in all subjects.; | — |
Countries
China
Contacts
Public ContactHuashan Shi, Chen Lei
West China Hospital, Sichuan University
Outcome results
None listed