Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated
Seasonal Influenza
About this trial
This is an interventional prevention trial for Seasonal Influenza
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects aged 9-59 years;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 9-17 years, both subjects and guardians need to sign the informed consent form).
- Proven legal identity.
Exclusion Criteria:
- Received seasonal influenza vaccine for 2022-2023 influenza season, or had an influenza vaccine schedule during the study;
- Suffering from seasonal influenza in the past 6 moths;
- Women of childbearing age (menarche to premenopause) are pregnant(including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- Patients with fever on the day of vaccination,underarm body temperature>37.2 ℃;
- History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Autoimmune disease or immune deficiency/immunosuppression;
- Thyroid disease or history of thyroidectomy,absence of spleen, functional functional asplenia,and absence of spleen or splenectomy as a result of any condition;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- A long history of alcohol or drug abuse;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
- Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days,receipt of inactivated or subunit vaccines in the past 7 days;
- The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials during the follow-up period;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sites / Locations
- Yuping Dong Autonomous County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3
420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 1.
420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 2.
420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 3.