influenza
Conditions
Interventions
Group A1:receive 1 dose of vaccine
Group A2:receive 1 dose of vaccine
??A3:receive 1 dose of vaccine
Group A4:receive 1 dose of vaccine
Group B:receive 2 dose of vaccine
Sponsors
He'nan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.5 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy people who are 6 to 35 months old, 3 years old and above; 2. The person or guardian or entrusted person has the ability to understand the clinical trial and agree to sign an informed consent; 3. Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no pregnancy or childbirth plans within 7 months after enrollment, and agreed to take effective contraceptive measures during this period. Effective contraceptive measures have been taken within 2 weeks before being selected; 4. Ability to comply with the requirements of the clinical trial program (fill in the diary card, contact card and participate in regular follow-ups).
Exclusion criteria
Exclusion criteria: 1. Body temperature on the day of enrollment: age =37.5?), age >14 years old (axillary temperature >= 37.3?); 2. Those who have a fever within 3 days before vaccination, and the axillary body temperature is >=38.0?; 3. (3 years old and above) the laboratory test indicators (blood routine, blood biochemistry) judged by the researcher are abnormal and have clinical significance; 4. Those who have been diagnosed with influenza infection in the past 6 months; 5. Vaccination of any influenza vaccine (registered or experimental) within the past 12 months or planned to receive any influenza vaccine during the study period; 6. Those who are allergic to any ingredients in the test vaccine, including eggs, excipients, formaldehyde and lysing agents, etc.; 7. Any previous history of severe allergies to vaccines or drugs (such as but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction)); 8. Acute onset of various acute diseases or chronic diseases in the past 7 days; 9. Suffer from severe respiratory disease, severe cardiovascular disease (heart disease, pulmonary heart disease, pulmonary edema, hypertension that cannot be controlled by drugs (>=18 years old, systolic blood pressure >=140mmHg and/or diastolic blood pressure >= 90mmHg)), Drug-controlled diabetes patients and malignant tumor patients; 10. Persons with progressive neurological diseases, with history of convulsions, epilepsy, encephalopathy, Guillain-Barré syndrome, mental illness or family history; 11. Suffer from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; 12. Asplenium, functional asplenia, as well as any spleen or splenectomy caused by any circumstances; those with other vital organs removed or partially removed; 13. Abnormal coagulation function (such as deficiency of coagulation factors, coagulopathy, abnormal platelet) or obvious bruise or coagulation disorder; 14. (Infants and young children aged 6 to 35 months) premature delivery (delivered before the 37th week of pregnancy), low weight (birth weight for girls < 2300g, boys < 2500g); 15. (Infants aged 6 to 35 months) who have a history of dystocia, suffocation rescue, or neurological damage; 16. Babies aged 6 to 11 months who are currently suffering from pathological jaundice or have suffered from pathological jaundice (lasting 2 to 4 weeks, recurring); 17. Congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc.; 18. Receive blood products within 3 months before receiving the test vaccine; 19. There is a history of attenuated live vaccination within 14 days before vaccination, and a history of other vaccination within 7 days; 20. Those who have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days); 21. Are or plan to participate in other clinical trials in the near future; 22. The investigator judges any situation that is not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions or events;Incidence of adverse reactions/events;Incidence of Serious Adverse Events (SAE);Antibody titer of various influenza virus serotypes;Incidence of abnormal indicators of blood routine;Incidence of abnormal indicators of blood routine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of abnormal indicators of liver and kidney function; | — |
Countries
China
Contacts
Public ContactHuang Lili
He'nan Provincial Center for Disease Control and Prevention
Outcome results
None listed