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

Primary Purpose

Seasonal Influenza

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Control Quadrivalent influenza virus vaccine
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

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital de Puerto MonttRecruiting
  • CIMER Center/Center for Medical Research on Respiratory DiseasesRecruiting
  • Clínica AlemanaRecruiting
  • Hospital Clínico UC-ChristusRecruiting
  • Hospital Felix BulnesRecruiting
  • Universidad San Sebastián
  • Clinica Alemana de ValdiviaRecruiting
  • Las Pinas Doctors Hospital
  • Tropical Disease Foundation Inc
  • San Juan De Dios Hospital
  • Philippine General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sinovac-QIV group

Vaxigrip Tetra-QIV group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2022
Last Updated
April 17, 2023
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05431725
Brief Title
Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

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
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.
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".

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2161 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sinovac-QIV group
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaxigrip Tetra-QIV group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Other Intervention Name(s)
Sinovac-QIV
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Control Quadrivalent influenza virus vaccine
Other Intervention Name(s)
Vaxigrip Tetra-QIV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seroconversion rates of HI antibody
Description
Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.
Time Frame
At day 28 after the last dose
Title
GMTs of HI antibody
Description
GMTs of HI antibody at day 28 after the last dose for each of the four antigens.
Time Frame
At day 28 after the last dose
Secondary Outcome Measure Information:
Title
Seroprotection rates(SCRs) of HI antibody
Description
Proportion of subjects with antibody titer ≥1:40 at day 28 after the last dose
Time Frame
At day 28 after the last dose
Title
Seroconversion rates (SCRs) of HI antibody
Description
Seroconversion rates at day 28 after the last dose.
Time Frame
At day 28 after the last dose
Title
Solicited local and systemic Adverse Events (AEs)
Description
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Events (AEs) within 7 days after each dose.
Time Frame
Within 7 days after each dose
Title
Unsolicited AEs
Description
Occurrence, intensity, duration, and relationship of unsolicited AEs within 28 days after each dose.
Time Frame
Within 28 days after each dose
Title
Serious adverse events (SAEs)
Description
Occurrence and relationship of serious adverse events (SAEs) within 28 days after each dose
Time Frame
Within 28 days after each dose
Title
Adverse events of special interest (AESI)
Description
Adverse events of special interest (AESI) within 28 days after each dose
Time Frame
Within 28 days after each dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Wanqi, Medical Manager
Phone
86-13051512756
Email
yangwq@sinovac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeng Gang, Senior Medical Director
Organizational Affiliation
Sinovac Biotech Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Puerto Montt
City
Puerto Montt
Country
Chile
Individual Site Status
Recruiting
Facility Name
CIMER Center/Center for Medical Research on Respiratory Diseases
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clínica Alemana
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Hospital Clínico UC-Christus
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Hospital Felix Bulnes
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Universidad San Sebastián
City
Santiago
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Clinica Alemana de Valdivia
City
Valdivia
Country
Chile
Individual Site Status
Recruiting
Facility Name
Las Pinas Doctors Hospital
City
Las Pinas
State/Province
Manila
Country
Philippines
Individual Site Status
Active, not recruiting
Facility Name
Tropical Disease Foundation Inc
City
Makati City
State/Province
Manila
Country
Philippines
Individual Site Status
Active, not recruiting
Facility Name
San Juan De Dios Hospital
City
Pasay
State/Province
Manila
Country
Philippines
Individual Site Status
Active, not recruiting
Facility Name
Philippine General Hospital
City
Manila
Country
Philippines
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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