Clinical trial NCT05512494: Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Influenza
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 1260
Sex: ALL
Minimum age (years): 9
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59 years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and 900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial scale,respectively.

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.

Primary outcomes:
measure: Immunogenicity index of GMT
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: Immunogenicity index of seroconversion rate
timeFrame: 28 days after vaccination
measure: Immunogenicity index of protection rate
timeFrame: 28 days after vaccination
measure: Immunogenicity index of GMI
timeFrame: 28 days after vaccination
measure: Safety index of the incidence of adverse reactions
timeFrame: From 0 to 28 days after vaccination.
measure: Safety index -The incidence of adverse reactions
timeFrame: From 0 to 7 days after vaccination.
measure: Safety index of the incidence of serious adverse events
timeFrame: From 0 to 28 days after vaccination
measure: Safety index of incidence of adverse events
timeFrame: From 0 to 28 days after vaccination
Other outcomes:
Locations:
city: Zhumadian
country: China
facility: Yuping Dong Autonomous County Center for Disease Control and Prevention
state: Guizhou
Study officials:
affiliation: Guizhou Provincial Center for Disease Prevention and Control
name: Qinghu Guan
role: PRINCIPAL_INVESTIGATOR
References: