Seasonal Influenza Clinical Trial
Official title:
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
Verified date | July 2022 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1260 |
Est. completion date | January 24, 2023 |
Est. primary completion date | January 24, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 59 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Yuping Dong Autonomous County Center for Disease Control and Prevention | Zhumadian | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity index of GMT | GMT of HI antibodies of each influenza strain at 28 days after vaccination. | 28 days after vaccination | |
Secondary | Immunogenicity index of seroconversion rate | Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination. | 28 days after vaccination | |
Secondary | Immunogenicity index of protection rate | Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer =1:40). | 28 days after vaccination | |
Secondary | Immunogenicity index of GMI | GMI of HI antibodies of each influenza strain at 28 days after vaccination. | 28 days after vaccination | |
Secondary | Safety index of the incidence of adverse reactions | Incidence of adverse reactions from 0 to 28 days after vaccination. | From 0 to 28 days after vaccination. | |
Secondary | Safety index -The incidence of adverse reactions | Incidence of adverse reactions from 0 to 7 days after vaccination. | From 0 to 7 days after vaccination. | |
Secondary | Safety index of the incidence of serious adverse events | Incidence of serious adverse events from 0 to 28 days after vaccination. | From 0 to 28 days after vaccination | |
Secondary | Safety index of incidence of adverse events | Incidence of adverse events of special concern from 0 to 28 days after vaccination. | From 0 to 28 days after vaccination |
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