Influenza caused by quadrivalent influenza virus split vaccine (MDCK cell) -associated influenza viruses
Conditions
Interventions
Intervention Group:Tetravalent influenza virus split vaccine (MDCK cells)
Positive control group:Tetravalent influenza virus split vaccine
placebo group:placebo
Sponsors
Shandong Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers aged 3-8: 1) The applicant should be 3 years old or less than 9 years old on the enrollment day, and be able to provide valid identification of the volunteer and his/her guardian; 2) Guardians of volunteers have the ability to understand the requirements and process of the study, agree to participate in the clinical trial and sign the informed consent (8-year-old volunteers also need to sign the informed consent for minors); 3) The guardians of the volunteers have the ability to understand the study procedures and attend all planned follow-up visits; 4) Axillary temperature =60 years old: 1) At least 60 years old on the enrollment day, and can provide valid identification; 2) Ability to understand research requirements and process, agree to participate in clinical trials, and sign informed consent; 3) Ability to understand study procedures and attend all planned follow-up visits; 4) Axillary temperature < 37.3 degree on the day of enrollment; 5) Have not received influenza vaccine in the past 2 years (from 2021 to now); 6) Agree to use effective contraception, no pregnancy and no family planning during the study (for male volunteers with female partners of reproductive age).
Exclusion criteria
Exclusion criteria: 1. Abnormal laboratory test indicators before immunization, and the abnormality is clinically significant as determined by the clinician; 2. Influenza vaccines other than those used in the study were planned during the study period; 3. Influenza illness (confirmed by clinical, serological or microbiological methods) within 3 months before enrollment; 4. Severe allergic history to any component of test vaccine (including bovine serum albumin, formaldehyde, TritonX-100, etc.), egg or egg protein, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local anaphylaxis and necrosis reaction (Arthus reaction); 5. Past history of serious adverse reactions to any vaccine or drug, such as allergy, urticaria, skin eczema, dyspnea, angiopanginal edema requiring medical intervention; 6. Acute illness or acute onset of chronic disease within 3 days before enrollment; 7. Before enrollment, the interval between vaccination with other non-live vaccines was less than 7 days, and the interval between vaccination with live attenuated vaccines and COVID-19 vaccines was less than 14 days; 8. Had fever (axillary temperature >=38.5 degree) within 3 days before enrollment, or was using antipyretic analgesics or antiallergic drugs within 3 days before enrollment; 9. Long-term use of immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) within 3 months before enrollment, such as glucocorticoid dose >=0.5mg/kg/ day (inhaled and local glucocorticoids are not restricted); 10. Received blood or blood-related products 6 months before enrollment; 11. Congenital malformations or inherited diseases (Down syndrome, thalassemia, congenital heart disease, etc.), acute or chronic infectious diseases (tuberculosis, various viral hepatitis, etc.), congenital or acquired immunodeficiency (HIV), etc., that may interfere with the conduct or completion of the study; 12. Suffers from a serious medical condition that may interfere with the conduct or completion of the study (including: Medication uncontrolled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg, only in people 18 years of age or older), heart disease, kidney disease, diabetes (unstable blood glucose control, or medication failure to control blood glucose, Or diabetic complications), autoimmune diseases, hereditary allergies, Guillain-Barre syndrome, infectious/allergic skin diseases, etc.); 13. There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or being treated with anticoagulants; 14. A history or family history of epilepsy, encephalopathy and mental illness, and a history of convulsions within six months; 15. Asplenia, functional asplenia, and asplenia or splenectomy resulting from any condition; 16. Plan to move out of town before the end of the study or for an extended period of time during the scheduled study visit; 17. Persons who are participating in another clinical trial and who plan to participate in other clinical trials during the clinical trial; 18. In the opinion of the investigator, the volunteers had any condition that might interfere with the evaluation of the study's purpose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events/reactions;Abnormal rate of laboratory test indicators;Incidence rate of serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive conversion rate and antibody level(GMT) of influenza virus types; | — |
Countries
China
Contacts
Public ContactLi Zhang
Shandong Provincial Center for Disease Control and Prevention
Outcome results
None listed