A Clinical Trial of an Quadrivalent Influenza Virus Subunit Vaccine in Chinese Children Aged 6 to 35 Months

Inclusion Criteria:

• 6-35 months healthy infants;

• The legal guardian voluntarily consented to the subject's participation in thestudy, and the legal guardian/trustee signed the Informed Consent Form and compliedwith the requirements of the protocol.

Exclusion Criteria:

1. Exclusion criteria for the first dose:

• Armpit temperature ≥37.3℃ on the day of enrollment;

• Persons infected with influenza virus confirmed by laboratory testing withinthe previous 6 months;

• Received any influenza vaccine (registered or experimental) within the previous 12 months or planned to receive any influenza vaccine during the study period;

• Allergic to any components of the vaccine, such as eggs, excipients,formaldehyde, etc;

• Previous history of severe allergy to any vaccine or drug (e.g., but notlimited to: anaphylactic shock, allergic laryngeal edema, allergic purpura,thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthusreaction);

• 6-23 months: premature (delivered before the 37th week of gestation), lowweight (birth weight <2500g) , or a history of dystocia, asphyxia rescue, andneurological damage;

• Congenital malformations or developmental disorders, genetic defects, severemalnutrition, etc;

• Acute disease, serious chronic disease or acute attack of chronic disease onthe day of vaccination;

• Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia,systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), orother autoimmune diseases;

• History of asthma, instability within the past two years requiring emergencytreatment, hospitalization, intubation, oral or intravenous corticosteroids;

• Progressive neurological disease, history of seizures, epilepsy,encephalopathy, Guillain-Barre syndrome, or history or family history of mentalillness;

• Suffering from serious cardiovascular disease (heart disease, pulmonary heartdisease, pulmonary edema);

• Asplenia, functional asplenia, and asplenia or splenectomy resulting from anycondition; Resection or partial resection of other important organs;

• History of coagulation dysfunction (e.g., coagulation factor deficiency,coagulation disease);

• A history of live attenuated vaccine vaccination within 14 days and a historyof other vaccines within 7 days before vaccination;

• Immune-boosting or suppressant therapy within 3 months (continuous oral orintravenous infusion for more than 14 days);

• Received blood or blood-related products;

• Plan to relocate prior to the completion of the study or to be away for anextended period during the scheduled study visit;

• Being or planning to participate in other clinical trials in the near future;

• Any ineligibility to participate in the trial was determined by theinvestigator.

2. Exclusion criteria for the second dose:

• Severe allergic reaction after the first dose of vaccine;

• Serious adverse reactions related to the first dose of vaccine;

• The investigator will decide whether to continue to participate in the study ifnew findings or new occurrence after the first dose inoculation do not meet theinclusion criteria of the first dose or the exclusion criteria of the firstdose;

• Other reasons for exclusion, according to the investigator.