influenza
Conditions
Interventions
Trial group:2 doses of trial vaccine for 28 days interval
Control group:1 dose of control vaccine
Sponsors
Hubei provincial center for disease control and prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 6 months and older, subjects(aged below 18 years)or their guardians informed consent, and signed the informed consent form; 2. The subjects and their guardians can comply with the requirements of clinical trial scheme; 3. Subjects did not take any attenuated live vaccine within 14 days, and did not take any inactivated vaccine within 7 days; 4. the axillary temperature <=37.0 degree C; 5. The registered permanent residence or resident place are local (reside more than 3 months); 6. After inquiry of medical history, physical examination and clinical judgement, subjects are deem as healthy, and be qualified to the products.
Exclusion criteria
Exclusion criteria: 1. Subjects with a known allergy to any ingredient of the vaccine(including eggs, excipients, formaldehyde, gentamycin sulfate and allergy to Triton X-100), and with any allergy history to any vaccine; 2. Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases,and catching cold and fever; 3. Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome; 4. Subjects have history of other vaccine immunoglobulin preparations and any investigational drug in the past 14 days; 5. Pregnant women; 6. Subjects have attended another clinical trial within 3 months; 7. Any situation which the researchers think that may affect test evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction rate;the antibody concentration of A1 A3 and B; | — |
Countries
China
Contacts
Public ContactJianjun Ye
Outcome results
None listed