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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01209780 -
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
|
Phase 3 | |
Completed |
NCT01180621 -
Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children
|
Phase 2 | |
Completed |
NCT01206686 -
The Effect of Time-Slot Scheduling on Flu Vaccination Rates
|
N/A | |
Recruiting |
NCT06049927 -
A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
|
Phase 3 | |
Completed |
NCT04133584 -
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
|
Phase 4 | |
Completed |
NCT05566639 -
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older
|
Phase 3 | |
Completed |
NCT01207232 -
The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
|
N/A | |
Completed |
NCT00957996 -
Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
|
Phase 3 | |
Completed |
NCT01072799 -
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
|
Phase 2 | |
Completed |
NCT04997239 -
A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
|
Phase 4 | |
Completed |
NCT01011582 -
Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza
|
N/A | |
Terminated |
NCT00958776 -
A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza
|
Phase 3 | |
Completed |
NCT00560066 -
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
|
Phase 4 | |
Active, not recruiting |
NCT05397223 -
A Study of Modified mRNA Vaccines in Healthy Adults
|
Phase 1 | |
Completed |
NCT04896086 -
First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults
|
Phase 1 | |
Completed |
NCT01344057 -
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
|
Phase 2 | |
Completed |
NCT01342796 -
Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects
|
Phase 2 | |
Completed |
NCT00903552 -
Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)
|
Phase 2 | |
Completed |
NCT05827068 -
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT05415462 -
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
|
Phase 3 |