Prevention of influenza caused by influenza virus
Conditions
Interventions
Experimental vaccine group A:On the 0th and 28th day, the inoculation is once each, a total of 2 times, each human dose is 0.25ml
Experimental vaccine group B:On the 0th and 28th day, the inoculation is once each, a total of 2 times, each human dose is 0.5ml
Control vaccine group C:On the 0th and 28th day, the inoculation is once each, a total of 2 times, each human dose is 0.25ml
Control vaccine group D:On the 0th and 28th day, the inoculation is once each, a total of 2 times, each human dose is 0.25ml
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
0.5 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1. Healthy cribs aged 6-35 months, provide vaccination certificate and birth medical certificate; 2. The legal guardian or trustee of the volunteer has informed consent, voluntarily participates and signs the informed consent; 3. The legal guardian or trustee of the volunteer has the ability (not illiterate) to understand the study procedures, has the ability to use thermometers, scales and fill in diary cards/contact cards as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol.
Exclusion criteria
Exclusion criteria: The First dose: 1. Axillary body temperature > 37.0 degree on the day of enrollment; 2. Aged 24-35 month, abnormal hematology, blood biochemistry and urine routine indexes and judged as clinically significant by the investigator; 3. Influenza in the past 3 months (confirmed by any clinical, serological or microbiological methods); 4. Have received any influenza vaccine (registered or experimental) in the past or have plans to receive any influenza vaccine during the study period; 5. Allergy to any component of the study vaccine, history of allergic reaction by eating eggs or using gentamicin sulfate; 6. History of severe allergy to any vaccine or drug; 7. Premature birth (delivery before the 37th week of pregnancy), low birth weight (birth weight 2500 g) babies (only applicable to volunteers from 6 months to 12 months old); 8. Dystocia, suffocation rescue, history of nervous system damage; 9. Congenital malformations or developmental disorders affecting organ function, genetic defects, severe malnutrition, etc.; 10. Acute disease, severe chronic disease or acute attack of chronic disease on the day of vaccination; 11. History of vaccination with live attenuated vaccines within 14 days and other vaccinations within 7 days before vaccination; 12. Those who have received immune enhancement or inhibitor therapy within 3 months (continuous oral or drip infusion for more than 14 days); 13. Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 14. History of asthma, unstable in the past two years requiring emergency treatment, hospitalization, catheterization, oral or intravenous corticosteroids; 15. Received blood or blood-related products within 3 months; 16. Patients with progressive neurological diseases, with a history of convulsions, epilepsy, encephalopathy, Guillain-Barre syndrome, a history of mental illness or family history; 17. Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); 18. Plans to move outside the country before the end of the study or leave the local area for a long time during the scheduled study visit; 19. Participating in or planning to participate in other clinical trials in the near future; 20. Abnormal laboratory test indicators, except for minor abnormalities that have no clinical significance as judged by the doctor; 21. Any condition judged by the investigator to be unsuitable for participation in this clinical trial. The second dose: 1. Those who have a severe allergic reaction after the first dose of vaccine; 2. Those with serious adverse reactions that are causally related to the first dose of vaccination; 3. Newly discovered or newly occurring after the first dose vaccination that does not meet the selection criteria for the first dose or meets the exclusion criteria for the first dose, the investigator will determine whether to continue to participate in the study; 4. Other reasons for exclusion as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event (AE);Serious Adverse Event (SAE);HI(hemagglutination Inhibition) antibody positive conversion rate;Seroprotection rate;HI antibody GMT(geometric mean titer);HI antibody GMI(geometric mean increase); | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Center for Disease Control and Prevention
Outcome results
None listed