A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old

PRO-QINF-4003

This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old.

2022-11-27

2023-01-24

2023-01-24

Completed

Early phase I

1260

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.

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2023-09-18