Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

May 24, 2024 updated by: Sinovac Biotech Co., Ltd

A Phase Ⅲ, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Individuals Aged 3 Years and Older

The purpose of this study is to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared to a licensed comparator in Chile and Philippines, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older.

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 phase Ⅲ, double-blind, randomized and active-controlled clinical trial to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared to a licensed comparator in Chile, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older. Subjects will be randomized 1:1 to received either Sinovac-QIV or Vaxigrip Tetra-QIV. Vaccine-primed subjects will receive one 0.5ml dose of Sinovac-QIV or Vaxigrip Tetra-QIV on day 0. Vaccine-unprimed subjects will receive two 0.5ml doses of Sinovac-QIV or Vaxigrip Tetra-QIV and day 0 and day 28, respectively. Subjects who are 3-8 years of age had prior receipt of ≥2 doses of influenza vaccine at least 4 weeks apart or who are ≥9 years old are considered "vaccine-prime". Subjects who are 3-8 years of age had prior receipt of <2 dose of influenza vaccine are considered "vaccine-unprimed".

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.
2202

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 3

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.
  • Name: Yang Wanqi, Medical Manager
  • Phone Number: 86-13051512756
  • Email: yangwq@sinovac.com

Study Locations

  • Chile
      • Puerto Montt, Chile
        • Hospital De Puerto Montt
      • Santiago, Chile
        • Clinica Alemana
      • Santiago, Chile
        • Universidad San Sebastián
      • Santiago, Chile
        • CIMER Center/Center for Medical Research on Respiratory Diseases
      • Santiago, Chile
        • Hospital Clínico UC-Christus
      • Santiago, Chile
        • Hospital Felix Bulnes
      • Valdivia, Chile
        • Clinica Alemana de Valdivia
  • Philippines
      • Manila, Philippines
        • Philippine General Hospital
    • Manila
      • Las Pinas, Manila, Philippines
        • Las Piñas Doctors Hospital
      • Makati City, Manila, Philippines
        • Tropical Disease Foundation Inc
      • Pasay, Manila, Philippines
        • San Juan De Dios Hospital

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

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteers age 3 years and older, in good health or medically stable;
  • Written informed consent obtained from subjects or/and legal guardian;
  • No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study;
  • Female subjects of non-child bearing may be enrolled in the study. Non-child bearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or premenarche or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause);

  • Female subjects of child bearing potential may be enrolled in the study, if the subject

    • Has a negative pregnancy test on the day of the first dose (day 0);
    • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose and until at least 28 days after vaccination.

Exclusion Criteria:

  • History of seasonal influenza within 6 months prior to the study entry;
  • Axillary temperature ≥37.3℃;
  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine;
  • History of allergy to any vaccine, or any ingredient of the experimental vaccine;
  • Serious adverse reaction(s) to the vaccine, such as urticaria, dyspnea or angioneurotic edem etc.;
  • History of serious neurological disorder (such as epilepsy, convulsions etc.) or a mental illness;
  • Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
  • Significant chronic illnesses that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but are not limited to cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver or kidney disorders, HIV infection or malignant tumor;
  • Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
  • Absence of spleen, functional absence of spleen, and absence or removal of spleen under any circumstances;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
  • Alcoholism or history of drug abuse；
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  • Received blood products within 3 months prior to study entry;
  • Received any live attenuated vaccine within 14 days prior to study entry or any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  • Pregnant women or lactating women;
  • Subjects participate other clinical trials (licensed or unlicensed vaccines, drugs, organisms, devices, blood products or drugs) during the study period;
  • Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

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: Double

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: Sinovac-QIV group
800 subjects aged 3 years and older will receive one dose of Sinovac-QIV for vaccine-primed subjects or two doses of Sinovac-QIV for vaccine-unprimed subjects.
Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
The influenza vaccines (Split Virion), inactivated, quadrivalent are developed by Sinovac Biotech Co., Ltd.15 μg hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride,disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region.
Other Names:
  • Sinovac-QIV
Active Comparator: Vaxigrip Tetra-QIV group
800 subjects aged 3 years and older will receive one dose of Vaxigrip Tetra-QIV for vaccine-primed subjects or two doses of Vaxigrip Tetra-QIV for vaccine-unprimed subjects.
Biological: Control Quadrivalent influenza virus vaccine
The Control Quadrivalent influenza virus vaccines are manufactured by Sanofi and are purchased by Pontifical Catholic University of Chile.15μg HA of each of the four influenza strains in 0.5 mL of solution per injection.The routine of administration is intramuscular injection into deltoid region.
Other Names:
  • Vaxigrip Tetra-QIV

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
Seroconversion rates of HI antibody
Time Frame: At day 28 after the last dose
Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.
At day 28 after the last dose
GMTs of HI antibody
Time Frame: At day 28 after the last dose
GMTs of HI antibody at day 28 after the last dose for each of the four antigens.
At day 28 after the last dose

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
Seroprotection rates(SCRs) of HI antibody
Time Frame: At day 28 after the last dose
Proportion of subjects with antibody titer ≥1:40 at day 28 after the last dose
At day 28 after the last dose
Seroconversion rates (SCRs) of HI antibody
Time Frame: At day 28 after the last dose
Seroconversion rates at day 28 after the last dose.
At day 28 after the last dose
Solicited local and systemic Adverse Events (AEs)
Time Frame: Within 7 days after each dose
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Events (AEs) within 7 days after each dose.
Within 7 days after each dose
Unsolicited AEs
Time Frame: Within 28 days after each dose
Occurrence, intensity, duration, and relationship of unsolicited AEs within 28 days after each dose.
Within 28 days after each dose
Serious adverse events (SAEs)
Time Frame: Within 28 days after each dose
Occurrence and relationship of serious adverse events (SAEs) within 28 days after each dose
Within 28 days after each dose
Adverse events of special interest (AESI)
Time Frame: Within 28 days after each dose
Adverse events of special interest (AESI) within 28 days after each dose
Within 28 days after each dose

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pontificia Universidad Catolica de Chile
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.
  • Study Director: Zeng Gang, Senior Medical Director, Sinovac Biotech Co., Ltd

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.
July 18, 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.
July 19, 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.
July 19, 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).
June 19, 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.
June 19, 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.
June 24, 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.
May 28, 2024

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.
May 24, 2024

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.
May 1, 2024

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-3004

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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