Influenza
Conditions
Interventions
trial group:2 dose of trial vaccine (trivalent) for 21 days interval (+/- 7days)
control group A:2 dose of vaccine A (tetravalent) for 21 days interval (+/- 7days)
Control group B:2 dose of vaccine B (trivalent) for 21 days interval (+/- 7days)
Sponsors
Hubei provincial center for disease control and prevention
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Healthy permanent residents aged 6 months to 3 years old; 2. Subjects'guardians or the subjects who are old than 10 years old 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; 4. The axillary temperature is not higher than 37.0 degree.
Exclusion criteria
Exclusion criteria: 1. Patients with influenza or having been infected with influenza within 3 months; 2. Subjects have any allergy history to vaccine or any ingredients of the experimental vaccine,such as eggs ,ovalbumin, etc; 3. There are serious side effects, such as allergies, hives, eczema, dyspnea, angioedema or abdominal pain; 4. Subjects with symptoms of acute infection within a week; 5. Subjects have a autoimmune disease or being immune deficiencies or have received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids within the past six months; 6. subjects with congenital malformations, developmental disorders or severe chronic (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders); 7. Subjects with asthma, being the instability phase and in need of emergency treatment ,hospitalization, intubation, oral or intravenous corticosteroids; 8. Subjects with a medical diagnosed coagulation abnormalities (such as clotting factor deficiency, coagulation disorders, platelet disorder) or significant bruising or coagulopathy; 9. Subjects with convulsions, epilepsy, encephalopathy, mental illness or a history of family medical history; 10. Subjects who are asplenia or functional asplenia, and any resulting asplenia or splenectomy; 11. Subjects with Guillain-Barre syndrome and other serious neurological and other diseases; 12. Subjects who received blood products or seasonal flu vaccine within a month; 13. Subjects who have attended another clinical trial within a month; 14. Subjects who received attenuated live vaccine within 14 days, any subunit or inactivated vaccine within 7 days; 15. Subjects who received allergy treatment within 14 days; 16. Subjects who are under therapeutic of anti-TB; 17. Subjects with a fever (axillary temperature> 37.0 degree); 18. Not suitable for clinical trials according the researchersjudgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction rate; | — |
Countries
China
Contacts
Public ContactBeifang Yang
Hubei provincial center for disease control and prevention
Outcome results
None listed