- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05512494
Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated
September 15, 2023 updated by: Sinovac Biotech Co., Ltd
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1260
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qinghu Guan
- Phone Number: 13087815811
- Email: 522649392@qq.com
Study Locations
-
-
Guizhou
-
Zhumadian, Guizhou, China, 554099
- Yuping Dong Autonomous County Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 59 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quadrivalent Influenza Vaccine (Split Virion), inactivated 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 1.
|
The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd.
The four influenza strains(including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
|
Experimental: Quadrivalent Influenza Vaccine (Split Virion), inactivated 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 2.
|
The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd.
The four influenza strains(including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
|
Experimental: 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 3.
|
The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd.
The four influenza strains(including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity index of GMT
Time Frame: 28 days after vaccination
|
GMT of HI antibodies of each influenza strain at 28 days after vaccination.
|
28 days after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity index of seroconversion rate
Time Frame: 28 days after vaccination
|
Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination.
|
28 days after vaccination
|
Immunogenicity index of protection rate
Time Frame: 28 days after vaccination
|
Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).
|
28 days after vaccination
|
Immunogenicity index of GMI
Time Frame: 28 days after vaccination
|
GMI of HI antibodies of each influenza strain at 28 days after vaccination.
|
28 days after vaccination
|
Safety index of the incidence of adverse reactions
Time Frame: From 0 to 28 days after vaccination.
|
Incidence of adverse reactions from 0 to 28 days after vaccination.
|
From 0 to 28 days after vaccination.
|
Safety index -The incidence of adverse reactions
Time Frame: From 0 to 7 days after vaccination.
|
Incidence of adverse reactions from 0 to 7 days after vaccination.
|
From 0 to 7 days after vaccination.
|
Safety index of the incidence of serious adverse events
Time Frame: From 0 to 28 days after vaccination
|
Incidence of serious adverse events from 0 to 28 days after vaccination.
|
From 0 to 28 days after vaccination
|
Safety index of incidence of adverse events
Time Frame: From 0 to 28 days after vaccination
|
Incidence of adverse events of special concern from 0 to 28 days after vaccination.
|
From 0 to 28 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qinghu Guan, Guizhou Provincial Center for Disease Prevention and Control
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2022
Primary Completion (Actual)
January 24, 2023
Study Completion (Actual)
January 24, 2023
Study Registration Dates
First Submitted
August 21, 2022
First Submitted That Met QC Criteria
August 21, 2022
First Posted (Actual)
August 23, 2022
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-QINF-4003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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