Prevention of influenza caused by influenza virus
Conditions
Interventions
Experimental vaccine:Influenza Vaccine(Subunit),Inactivated,Quadrivalent (MDCK cell)(Changchun Institute of Biological Products Co., Ltd)::Each dose is 0.5mL, injected into the deltoid muscle on the l
Control vaccine 1+Control vaccine 2:Control vaccine 1 is a tetravalent influenza virus split vaccine (Changchun Institute of Biological Products Co., Ltd.): a human dose of 0.5mL is administered every
Sponsors
Hubei Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: Selection criteria for the population aged 3-8: 1. If the age is over 3 years old but under 9 years old, provide legal identification documents for the subject and their guardian; 2. The subject's guardian has the ability to understand the research requirements and process, agrees to participate in clinical trials, and signs an informed consent form; 3. The legal guardian of the subject has the ability to understand the research procedure and participate in all planned follow-up; 4.On the day of enrollment, axillary temperature = 37.0 ?; 5.Applicable to the population aged 3-8 who have received previous doses of influenza vaccine: Children who have received 2 or more doses of influenza vaccine (with an interval of = 4 weeks) one year ago do not need to receive 2 doses of influenza vaccine in the same or consecutive epidemic seasons. It can be understood as children who have accumulated 2 or more doses of influenza vaccine. Selection criteria for individuals aged 9 and above: 1. At least 9 years old, able to provide legal identification documents of the subject and/or their guardian; 2. The subjects and/or their guardians have the ability to understand the research requirements and process and agree to participate in the clinical trial; 3. The subjects and/or their guardians have the ability to understand the research procedures and participate in all planned follow-up visits; 4.On the day of enrollment, axillary temperature = 37.0 ?; 5. If the urine pregnancy test is negative and not during lactation, consent is given to effective contraceptive measures during the study period, and there is no pregnancy or childbirth plan (applicable to female subjects of childbearing age).
Exclusion criteria
Exclusion criteria: 1. Applicable to individuals aged 9 and above and those aged 3-8 who have received any influenza vaccine (registered or experimental) within the past year or have planned to receive any other influenza vaccine during the study period; 2.Applicable to the population aged 3-8 who have not been vaccinated in the past: those who have received any influenza vaccine (registered or experimental) in the past or have planned to receive any other influenza vaccine during the study period; 3. Applicable to all populations in the 3-8 age group: those with abnormal growth and development 4. Suffering from influenza disease within the past six months (confirmed by clinical, serological, or microbiological methods); 5. Abnormal blood routine, blood biochemistry, and urine routine indicators that have been determined by researchers to be clinically significant; 6. Any known or suspected allergy to any component of the influenza vaccine; Individuals with a history of severe allergic reactions (including allergic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis, etc.) or a history of allergic reactions using gentamicin sulfate or a history/current severe eczema; 7. Suffering from acute diseases and being in the acute phase of chronic diseases; 8. Suspected progressive neurological disorders, epilepsy, convulsions or convulsions, or family history of mental illness; 9. Autoimmune diseases or immunodeficiency, or long-term use of immunosuppressants or other immunomodulatory drugs (= 14 days or dose = 2 mg/kg/day or = 20 mg/day prednisone or equivalent dose) within the first 3 months before enrollment, but local medication is not restricted (such as ointments, eye drops, inhalers, or nasal sprays); 10. Suffering from serious congenital malformations or chronic diseases that may interfere with the progress or completion of the study (including but not limited to Down's syndrome, thalassemia, heart disease, kidney disease, diabetes, autoimmune disease, Greenberry syndrome, etc.); 11. Asthma, unstable condition within the first two years of screening period, or emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; 12. Suffering from febrile diseases within 3 days prior to vaccination, or using antipyretic and analgesic drugs and/or anti allergic drugs within 3 days prior to vaccination; 13. Absence of spleen, functional absence of spleen, and any situation leading to absence of spleen or splenectomy; 14. There are contraindications for intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorders, or receiving anticoagulant treatment; 15. Use immunoglobulins and/or any blood products within 3 months prior to enrollment, or plan to use them during the trial period (before completing post immunization blood sample collection); 16. Those who have received attenuated live vaccines within 14 days before the trial or other vaccines within 7 days; 17. Participants who are currently participating or planning to participate in other clinical trials during the study period (authorized or unlicensed vaccines, drugs, organisms, devices, blood products or drugs); 18. Those who may be away from the local area, have social or language barriers, or have other situations that affect communication during the experiment; 19. According to the researcher's judgment, there are any other factors that are not suitable for the subject to participate in the clinical trial. Suspension cr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events/reactions within 30 minutes after each dose of vaccination;The incidence of adverse events/reactions (including laboratory test indicators that are abnormal and clinically significant) within 0-7 days after each dose of vaccination;The incidence of adverse events/reactions within 0-28 days after each dose of vaccination;Serious adverse events (SAE) within 6 months after the first dose to the last dose;Pregnancy events within 6 months after vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT, seroconversion rate (SCR), serum protection rate (SPR), and GMT growth factor (GMI) of HI antibodies against various types of influenza virus in the population aged 3 and above 28 days after the first dose of vaccination;The entire population aged 3-8 who have not been vaccinated with influenza vaccine after the second dose of vaccination 28 days after vaccination against various types of influenza virus HI antibodies GMT, SCR, SPR, and GMI;Susceptible individuals aged 3 years and above, and individuals with pre vaccination serum HI titers<1:40. 28 days after the first dose of vaccination, all types of HI antibodies against influenza virus, including GMT, SCR, SPR, and GMI, were tested;Susceptible individuals aged 3-8 who have not been vaccinated with influenza vaccine, as well as individuals with pre vaccination serum HI titers<1:40. After 28 days of vaccination with the second dose, all types of influenza virus HI antibodies GMT, SCR, SPR, and GMI related to the vaccine were detected; | — |
Countries
China
Contacts
Public ContactYang Beifang
Hubei Center for Disease Control and Prevention
Outcome results
None listed