inlfuenza virus infection
Conditions
Interventions
Low dose 6-35 months age group:2 low dose of trial vaccine(subunit quadrivalent inactived subunit influenza virus vaccine) for 28 days interval (+/- 7days)
High dose 6-35 months age group :2 high dose of trial vaccine(subunit quadrivalent inactived subunit influenza virus vaccine) for 28 days interval (+/- 7days)
3-8 years age experimental group:2 high dose of trial vaccine(subunit quadrivalent inactived subunit influenza virus vaccine)
3-8 years age control group:2 dose of control vaccine(split-virion quadrivalent inactived subunit influenza virus vaccine)
9-17 years age experimental group:1 high dose of trial vaccine(subunit quadrivalent inactived subunit influenza virus vaccine)
9-17 years age control group:1 dose of control vaccine(split-virion quadrivalent inactived subunit influenza virus vaccine)
>=18 years age eperimental group:1 high dose of trial vaccine(subunit quadrivalent inactived subunit influenza virus vaccine)
>=18 years age control group:1 dose of control vaccine(split-virion quadrivalent inactived subunit influenza virus vaccine)
Sponsors
Henan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.5 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy people aged 6 months and above; 2. Subjects or his/her guardians agree to participate the trial, and signed the informed consent form; 3. The subjects and their guardians can comply with the requirements of clinical trial scheme.
Exclusion criteria
Exclusion criteria: 1. The axillary temperature is higher than 37.0 degree centigrade; 2. people aged 3-8 years had injected influenza vaccines; Aged >=9 years people had injected influenza vaccines in the past year; 3. Do not be infected by influenza virus in the past year; 4. subjects with congenital malformations, developmental disorders or severe chronic (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders); 5. Subjects with convulsions, epilepsy, encephalopathy, mental illness or a history of family medical history; 6. Subjects with Guillain-Barre syndrome and other serious neurological and other diseases; 7. Subjects have received immunosuppressive therapy, immunoenhancement within the past three months (oral or instill for 14 days); 8. Subjects have a autoimmune disease, HIV infection, lymphoma, leukemia or other immunodefficient diseases; 9. Severe liver or renal diseases, cancers, other acute diseases or chronic diseases; 10. Subjects with a medical diagnosed coagulation abnormalities (such as clotting factor deficiency, coagulation disorders, platelet disorder) or significant bruising or coagulopathy; 11. Subjects have being immune deficiencies (removal history of thyroid, pancreas, liver, spleen; need to treat due to thyroid disease in the past 12 months); 12. Subjects have any allergy history to vaccine; 13. Subjects have any allergy to any ingredients of the experimental vaccine, especially, eggs; 14. Subjects who received attenuated live vaccine within 14 days, any subunit or inactivated vaccine within 7 days; 15. Subjects who have attended /will attend another clinical trial; 16. Not suitable for clinical trials according the researchers judgement; 17. Subjects who have premature delivery(pregnant 37 weeks before delivery),low weight infant(Birth weight, girl 140mmHg or diastolic pressure > 90mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction rate;The GMT antibody concentration of A1, A3 and B; | — |
Countries
China
Contacts
Public ContactZhang Yuhui
Center for Ab&b Biotechnology Co., Ltd
Outcome results
None listed