Prevention of influenza caused by influenza virus
Conditions
Interventions
group A:Tetravalent influenza virus split vaccine (Changchun Biological Products Research Institute Co., Ltd.) 0.25 ml
group B:Tetravalent influenza virus split vaccine (Changchun Biological Products Research Institute Co., Ltd.) 0.5 ml
group C:Tetravalent influenza virus split vaccine (Hualan Biological Vaccine Co., Ltd.) 0.25 ml
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
0.5 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1. For healthy infants aged 6-35 months, provide vaccination certificate, birth medical certificate or household registration booklet; 2. Volunteer legal guardian or entrusted informed consent, voluntary participation and signed informed consent; 3. The volunteer's legal guardian or entrusted person has the ability (non-literate) to understand the research procedure, has the ability to use a thermometer, a scale, and fill in a diary card/contact card as required, and can complete the clinical research in compliance with the requirements of the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1. The first dose of vaccination: (1) Armpit body temperature > 37.0°C on the day of enrollment; (2) Suffered from influenza within the past year (judged by clinical, serological or microbiological methods); (3) Have received any influenza vaccine (registered or experimental) in the past or plan to receive any influenza vaccine during the study; (4) Allergic to any component of the research vaccine, with a history of allergic reactions to eating eggs or using gentamicin sulfate; (5) Have a history of severe allergy to any vaccine or drug in the past; (6) Preterm birth (delivery before the 37th week of pregnancy), low birth weight (weight at birth < 2500 g) infants (only applicable to volunteers aged 6 months to 12 months); (7) Those with a history of dystocia, suffocation rescue, and nervous system damage; (8) Congenital malformations or developmental disorders affecting organ functions, genetic defects, severe malnutrition, etc.; (9) Acute disease, severe chronic disease or acute attack of chronic disease on the day of vaccination; (10) Have a history of attenuated live vaccine vaccination within 14 days before vaccination, and have a history of other vaccination within 7 days; (11) Those who received immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days); (12) Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; (13) History of asthma, unstable in the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; (14) Received blood or blood-related products within 3 months; (15) People with progressive nervous system diseases, history of convulsions, epilepsy, encephalopathy, Guillain-Barré syndrome, psychiatric history or family history; (16) History of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); (17) Plan to move out before the end of the study or leave the local area for a long time during the scheduled study visit; (18) Are currently or plan to participate in other clinical trials in the near future; (19) The investigator judges that it is not suitable for participating in this clinical trial; 2. The second dose of vaccination: (1) Those who have severe allergic reactions after the first dose of vaccination; (2) Serious adverse reactions that are causally related to the first dose of vaccination; (3) After the first dose of vaccination, those who are newly discovered or newly discovered and do not meet the first dose of inclusion criteria or meet the first dose of exclusion criteria, the investigator will determine whether to continue to participate in the study; (4) Other reasons for exclusion considered by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion rate of all types of HI antibodies of the whole population 30 days after the whole course of immunization: the positive conversion rate of the test group and the control group should reach the relative standard of non inferiority comparison;All types of HI antibody GMT of the whole population 30 days after full immunization: the antibody GMT of the test group and the control group should meet the relative standard of non inferiority comparison;Incidence rate of adverse events (AE)/adverse reactions within 7 days after each dose of inoculation in each group;Incidence rate of adverse events (AE)/adverse reactions within 30 days from the first dose of vaccine to the full course of immunization in each group;Incidence rate of serious adverse events (SAE)/serious adverse reactions within 6 months from the first dose of vaccine to the full course of immunization in each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum HI antibody positive conversion rate/GMT/serum antibody protection rate 30 days after full immunization for susceptible population before immunization/negative population before immunization;Serum HI antibody GMI of susceptible population before immunization/negative population before immunization/whole population 30 days after full immunization; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Outcome results
None listed