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Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

Primary Purpose

Seasonal Influenza

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Quadrivalent Influenza Vaccine (Split Virion), inactivated
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza

Eligibility Criteria

9 Years - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yuping Dong Autonomous County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Immunogenicity index of GMT
GMT of HI antibodies of each influenza strain at 28 days after vaccination.

Secondary Outcome Measures

Immunogenicity index of seroconversion rate
Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination.
Immunogenicity index of protection rate
Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).
Immunogenicity index of GMI
GMI of HI antibodies of each influenza strain at 28 days after vaccination.
Safety index of the incidence of adverse reactions
Incidence of adverse reactions from 0 to 28 days after vaccination.
Safety index -The incidence of adverse reactions
Incidence of adverse reactions from 0 to 7 days after vaccination.
Safety index of the incidence of serious adverse events
Incidence of serious adverse events from 0 to 28 days after vaccination.
Safety index of incidence of adverse events
Incidence of adverse events of special concern from 0 to 28 days after vaccination.

Full Information

First Posted
August 21, 2022
Last Updated
September 15, 2023
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05512494
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 27, 2022 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Influenza Vaccine (Split Virion), inactivated
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunogenicity index of GMT
Description
GMT of HI antibodies of each influenza strain at 28 days after vaccination.
Time Frame
28 days after vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index of seroconversion rate
Description
Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination.
Time Frame
28 days after vaccination
Title
Immunogenicity index of protection rate
Description
Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).
Time Frame
28 days after vaccination
Title
Immunogenicity index of GMI
Description
GMI of HI antibodies of each influenza strain at 28 days after vaccination.
Time Frame
28 days after vaccination
Title
Safety index of the incidence of adverse reactions
Description
Incidence of adverse reactions from 0 to 28 days after vaccination.
Time Frame
From 0 to 28 days after vaccination.
Title
Safety index -The incidence of adverse reactions
Description
Incidence of adverse reactions from 0 to 7 days after vaccination.
Time Frame
From 0 to 7 days after vaccination.
Title
Safety index of the incidence of serious adverse events
Description
Incidence of serious adverse events from 0 to 28 days after vaccination.
Time Frame
From 0 to 28 days after vaccination
Title
Safety index of incidence of adverse events
Description
Incidence of adverse events of special concern from 0 to 28 days after vaccination.
Time Frame
From 0 to 28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghu Guan
Organizational Affiliation
Guizhou Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuping Dong Autonomous County Center for Disease Control and Prevention
City
Zhumadian
State/Province
Guizhou
ZIP/Postal Code
554099
Country
China

12. IPD Sharing Statement

Learn more about this trial

Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

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