influenza
Conditions
Interventions
9-59 years old:Experimental vaccine
9-59 years old:Control vaccine
3-8 years old:Experimental vaccine
3-8 years old:Control vaccine
=60 years old:Experimental vaccine
=60 years old:Control vaccine
Sponsors
Shandong Provincial Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: 3-8 year old subjects: 1) On the day of enrollment, if the participant is at least 3 years old and under 9 years old, valid identification documents of the participant and their guardian can be provided; 2) The subject guardian has the ability to understand the research requirements and process, agree to participate in clinical trials, and sign an informed consent form (8-year-old subjects also need to sign an informed consent form for minors); And the subjects can participate in all planned follow-up visits; 3) On the day of enrollment, axillary temperature<37.3 ?; 4) Participants who have received influenza vaccine in the past are required to have received one or more doses of influenza vaccine before 2021 (who have not received influenza vaccine since 2021). Participants who have not received influenza vaccine in the past are required to have not received any influenza vaccine in any pandemic season before enrollment. 9-59 year old subjects: 1) On the day of enrollment, if they are 9 years old and under 60 years old, they must provide valid identification of the subject themselves, and if they are 9-17 years old, they must also provide valid identification of their guardian; 2) The subject/guardian has the ability to understand the research requirements and process, and can participate in all planned follow-up visits, and sign an informed consent form. Subjects aged 9-17 also need to sign an informed consent form for minors; 3) On the day of enrollment, axillary temperature<37.3 ?; 4) I have not been vaccinated against influenza in the past 2 years (2021 to present); 5) Negative urine pregnancy test (applicable to female subjects of childbearing age); 6) Female subjects of childbearing age during non pregnancy and non lactation periods; 7) Agree to adopt effective contraceptive measures during the study period, without pregnancy or birth plans (applicable to female subjects with fertility and male subjects with partners of women of childbearing age). Subjects = 60 years old: 1) At least 60 years old on the day of joining the group, able to provide valid identification; 2) Ability to understand research procedures, agree and participate in all planned follow-up visits; 3) On the day of enrollment, axillary temperature<37.3 ?; 4) I have not been vaccinated against influenza in the past 2 years (2021 to present); 5) Agree to use effective contraceptive measures during the study period, without pregnancy or family planning (applicable to male subjects with female partners of childbearing age).
Exclusion criteria
Exclusion criteria: First dose exclusion criteria: 1) During the study period, there was a plan to receive influenza vaccines other than those used in this experiment; 2) Suffering from influenza disease (confirmed by clinical, serological, or microbiological methods) within 3 months prior to enrollment; 3) Have a history of severe allergies to any component of the experimental vaccine (including but not limited to: bovine serum albumin, formaldehyde, TritonX-100, etc.), such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthur reaction); 4) Have any previous history of serious adverse reactions to vaccines or drugs, such as allergies, urticaria, skin eczema, respiratory difficulties, angioneurotic edema, etc. that require medical intervention; 5) Within 3 days prior to enrollment, suffer from acute illness or be in the acute phase of chronic illness; 6) Before enrollment, the interval between vaccination of other non live vaccines was less than 7 days, and the interval between vaccination of attenuated live vaccine and COVID-19 vaccine was less than 14 days; 7) Fever (axillary temperature = 38.5 ?) within 3 days prior to enrollment, or use of antipyretics, analgesics, or anti allergic drugs within 3 days prior to enrollment; 8) Long term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first 3 months of enrollment, such as a glucocorticoid dose of = 0.5mg/kg/day (inhalation and local glucocorticoids are not restricted); 9) Received blood or blood related products 6 months before enrollment; 10) Suffering from congenital malformations or genetic diseases (Down syndrome, thalassemia, congenital heart disease, etc.) that may interfere with the conduct or completion of research, acute and chronic infectious diseases (tuberculosis, various types of viral hepatitis, etc.), congenital or acquired immunodeficiency (HIV), etc; 11) Suffering from serious illnesses that may interfere with the conduct or completion of the study (including respiratory diseases such as asthma or hypertension that cannot be controlled by medication during the onset of chronic bronchitis (18-59 years old: systolic blood pressure = 140mmHg and/or diastolic blood pressure = 90mmHg; = 60 years old: systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg), heart disease, kidney disease Diabetes (unstable blood sugar control, or drugs unable to control blood sugar, or diabetes complications), autoimmune diseases, hereditary allergies, Guillain Barre syndrome, severe developmental disorders, infectious/allergic skin diseases, etc.); 12) There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorders, or receiving anticoagulant treatment; 13) Have a history of epilepsy, encephalopathy, and mental illness or family history, with a history of convulsions within six months; 14) Absplenia, functional absence of spleen, and any condition leading to absence of spleen or splenectomy; 15) Plan to move out of the local area before the end of the study or leave the local area for a long time during the scheduled study visit; 16) Those who are participating in another clinical trial and those who plan to participate in other clinical trials during the clinical trial period; 17) The researchers believe that there are any conditions in the subjects that may interfere wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serological Conversion Rate, Geometric Mean Titer and Seroprotection Rate rate of HI antibodies in serum of influenza virus H1N1, H3N2, B (V), B (Y) types;Incidence rate of adverse events/serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Fold Increase,GMI; | — |
Countries
China
Contacts
Public ContactLi Zhang
Shandong Provincial Center for Disease Prevention and Control
Outcome results
None listed