seasonal influenza virus infection
Conditions
Interventions
Experimental group 1 (never vaccinated against influenza virus before):Vaccination with inactivated quadrivalent influenza virus split vaccine
Experimental group 2 (previously vaccinated with one dose of influenza virus vaccine):Vaccination with inactivated quadrivalent influenza virus split vaccine
Experimental group 3 (previously received two doses of influenza virus vaccine):Vaccination with inactivated quadrivalent influenza virus split vaccine
Sponsors
Wuhan Institute of Biological Products Co., Ltd.
Eligibility
Sex/Gender
All
Age
3 Years to 9 Years
Inclusion criteria
Inclusion criteria: 1. Those who are over 3 years old and under 9 years old on the day of enrollment, can provide valid identity certificates of the subjects themselves and/or their guardians; 2. The subject's guardian has the ability to understand the research requirements and process, agree to participate in the clinical trial and sign the informed consent form (8-year-old subjects: The subjects themselves and their guardians voluntarily agree to participate in the research, their guardians sign the informed consent form, and the subjects themselves sign the minors' informed consent form; Subjects aged 3-7: The subject's guardian voluntarily consents to the child's participation in the research, and the guardian signs the informed consent form); 3. The subject's guardian has the ability to understand the research procedures, and the subject and/or his guardian can participate in all planned follow-up visits; 4. Axillary temperature <37.5? on the day of enrollment.
Exclusion criteria
Exclusion criteria: 1. Have a history of severe allergy to any component of the test vaccine (including eggs, ovalbumin, etc.), such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction); 2. Influenza patients or those with flu-like symptoms within 3 months (fever =38°C), accompanied by one of cough or sore throat); 3. Any history of serious adverse reactions to vaccines or drugs in the past, such as allergies, urticaria, skin eczema, dyspnea, angioedema, etc., which the investigators judged to be inappropriate; 4. Suffering from acute disease or acute exacerbation of chronic disease within 3 days before vaccination; 5. The interval between vaccination with other inactivated vaccines is less than 7 days, and the interval between vaccination with live attenuated vaccines is less than 14 days before enrollment; 6. Fever or using antipyretic analgesics and antiallergic drugs 3 days before enrollment; 7. Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months before enrollment (defined as continuous use for more than 14 days), if the glucocorticoid dose is >= 0.5 mg/kg/day (inhaled and topical glucocorticoids are not limited); 8. Received blood or blood-related products 6 months before enrollment; 9. Has been diagnosed with congenital or acquired immunodeficiency; 10. Have a serious disease or congenital malformation that may interfere with the conduct or completion of the study (Including but not limited to those who are judged inappropriate by the investigator: those with respiratory diseases such as asthma or during the onset of chronic bronchitis, Down syndrome, thalassemia, heart disease, kidney disease, autoimmune disease, hereditary allergy, Guillain-Barre Syndrome, current skin disease, etc.); 11. Has been diagnosed with a systemic disease that may interfere with the conduct or completion of the study, such as tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV infection determined by the investigator to be inappropriate; 12. History or family history of convulsions, epilepsy, encephalopathy and mental illness; 13. There are contraindications to intramuscular injection, such as: have been diagnosed with thrombocytopenia, any coagulation disorder, or receive anticoagulant treatment, etc.; 14. Asplenia, functional asplenia, and asplenia or splenectomy caused by any condition; 15. Plan to move out of the locality before the end of the study or for an extended period of time during the scheduled study visit; 16. The investigator believes that the subject has any condition that may interfere with the evaluation of the purpose of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody seroconversion rate of HI antibodies against four virus types of influenza vaccine;Geometric mean titers of HI antibodies against four virus types in influenza vaccine;Serological protection rate of HI antibodies against four virus types of influenza vaccine;Geometric mean growth multiples of HI antibodies against four virus types of influenza vaccine; | — |
Countries
China
Contacts
Public ContactZhang Jikai
Outcome results
None listed