influenza
Conditions
Interventions
group with a history of immunization:All subjects received 2 doses of IIV4 vaccine, 0.5ml per dose, according to the 0, 28-day immunization schedule.
No immunization history group:All subjects received 2 doses of IIV4 vaccine, 0.5ml per dose, according to the 0, 28-day immunization schedule.
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Inclusion criteria
Inclusion criteria: 1. The target group should be aged 3 to 9 years old on the day of enrollment; 2. The legal guardian has signed the informed consent, and the subjects over 8 years old have signed the informed acceptance; 3. Subjects and their guardians are able to participate in all planned visits and are able to comply with all study procedures; 4. Those with a history of immunization: Children who have received 2 or more doses of influenza vaccine (interval >= 4 weeks) before this influenza season (2 doses of influenza vaccine do not need to be vaccinated in the same epidemic season or consecutive epidemic seasons, understandable Children who have been vaccinated for 2 or more times); those without immunization history: children who have not been vaccinated before this influenza season or who have received less than 2 doses of influenza vaccine in the past; 5. Underarm body temperature <=37.0 degree.
Exclusion criteria
Exclusion criteria: First dose exclusion criteria: 1. Have used any investigational or unregistered product (drug, vaccine or device) within 30 days prior to enrollment, or plan to use it during the study; 2. Receive any influenza vaccine (registered or research) within 6 months before enrollment, or plan to use it during the study; 3. Long-term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within 3 months before enrollment, such as glucocorticoid dose of ?0.5mg/kg/day (inhaled and topical steroids are not Restricted); 4. Use of immunoglobulin and/or any blood product within 3 months before enrollment, or plan to use it during the study (before blood sample collection after immunity); 5. The interval between vaccination with other vaccines is less than 7 days before enrollment, and the interval between vaccination with live attenuated vaccine is less than 14 days; 6. History of Guillain-Barre syndrome with previous influenza vaccination; 7. Any known or suspected allergy to any component (including egg protein) or component of influenza vaccine; history of allergic reaction to eating eggs, or history of severe allergic reaction (including anaphylactic shock, allergic throat) after previous vaccination with other vaccines edema, allergic purpura, local allergic necrosis); 8. Those with acute illness/infection (according to the investigator's judgment) on the day of vaccination; 9. Any obvious abnormal coagulation function or history of anticoagulation therapy; 10. Any confirmed or suspected immunosuppressive or immunodeficiency disease; 11. Suffering from congenital heart disease or other birth defects that are not suitable for vaccination; 12. Currently suffering from respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver, kidney diseases, mental disorders, or chronic infections; 13. According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial. Second dose exclusion criteria: 1. Newly discovered or newly occurred situations that meet the first exclusion criteria before vaccination (inoculation can be postponed if items 5 and 8 of the exclusion criteria are met); 2. Severe allergic reaction during the first dose of vaccination; 3. A serious adverse event related to the previous vaccination occurred.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody positive rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody Geometric Mean Titer;Geometric mean growth;The proportion of people who reach protective antibody levels;Adverse Drug Reaction(ADR)Incidence rate; | — |
Countries
China
Contacts
Public ContactJiang Wei
Changchun Institute of Biological Products Co., Ltd
Outcome results
None listed