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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
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.
Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
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.
Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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