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Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile (TetraFluVac)

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ClinicalTrials.gov Identifier: NCT05494047
Recruitment Status : Recruiting
First Posted : August 9, 2022
Last Update Posted : August 9, 2022
Sponsor:
Collaborators:
Sinovac Biotech (Chile) SpA
Sinovac Biotech Co., Ltd
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Study Description
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Brief Summary:
This study compares the immunogenity and safety of quadrivalent inactivated influenza vaccines. The experimental group receives the quadrivalent influenza vaccine developed by Sinovac Biotech Co., Ltd and the control group immunized with Vaxigrip Tetra™. The group has 1600 persons from general population 3 years and older. The design is double-blind and randomized. The primary outcome is the immunogenicity against the 4 strains of influenza included in both vaccines.

Condition or disease Intervention/treatment Phase
Influenza Vaccines Drug: Tetravalent influenza vaccine developed by Sinovac Biotech Co. Phase 3

Detailed Description:
The study is designed to evaluate the immunogenicity of the quadrivalent inactivated-virus influenza vaccine developed by Sinovac Biotech Co., Ltd against Vaxigrip Tetra™. The population included in the study is healthy subjects 3 years and older, being 800 individuals 10 years old or less and 800 over 18 years, randomized 1:1 to experimental vaccine or Vaxigrip Tetra™. Volunteers 8 years old or less, without history of previous influenza infection will receive 2 doses of vaccine, al other individuals will receipt 1 dose of vaccine. Immunogenicity will be assessed one month after the last dose of vaccine, humoral responses will be determined for all patients meanwhile ome subgroup of patients will have a determination of cellular immunity also. Subjects will be follow up for one month, adverse events will be assessed during this time.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individuals will be randomized to receive Vaxigrip Tetrs TM or equivalent vaccine developed by Sinovac Biotech Co. It is a a comparative, double blind, propsective clinical trial with 2 active compunds.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Subjects will be randomized by a computer system. Investigators and care providers will not be able to know the vaccine administered. Statistical analysis will not have access to the information of immunization. Nonetheless, personnel study who will administer the vaccine will know the group because they will have access to the envelope of the vaccine then this personnel will not have any other responsibility during the study moreover, they will not have mantain regular contact with investigational team.
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine, Inactivated, Quadrivalent Developed by Sinovac Biotech Co., Ltd. Compared to a Licensed Quadrivalent Influenza Vaccine, VaxigripTetra™, in Individuals Aged 3 Years and Older in Chile
Actual Study Start Date : July 14, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tetravalent influenza vaccine developed by Sinovac Biotech Co.
The group will be formed by 800 individuals. 200 from 3 to 8 years old, 200 from 9 to 17 years old, 200 from 18 to 64 years old and 200 subjects 65 years and older. They will receive an unique dose of the tetravalent influenza vaccine developed by Sinovac Biotech Co.(H1N1, H3N2 and 2 strains of influenza B). Subjects 3 to 8 years will receive 2 doses of influenza vaccine unless they have receipt of 2 previous doses of any influenza vaccine or they have an history of previous influenza.
 Drug: Tetravalent influenza vaccine developed by Sinovac Biotech Co.
15μg Hemagglutinin Antigen (HA) of each of the four strains
Other Name: Sinovac vaccine
Active Comparator: Vaxigrip Tetra TM
The group will be formed by 800 individuals. 200 from 3 to 8 years old, 200 from 9 to 17 years old, 200 from 18 to 64 years old and 200 subjects 65 years and older. They will receive an unique dose of the tetravalent influenza vaccine Vaxigrip Tetra TM(H1N1, H3N2 and 2 strains of influenza B). Subjects 3 to 8 years will receive 2 doses of influenza vaccine unless they have receipt of 2 previous doses of any influenza vaccine or they have an history of previous influenza.
 Drug: Tetravalent influenza vaccine developed by Sinovac Biotech Co.
15μg Hemagglutinin Antigen (HA) of each of the four strains
Other Name: Sinovac vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion for influenza [ Time Frame: 28 days after the last dose of vaccination ]
    Seroconversion rates and geometric mean titers of human influenza antibody for each of the four antigens.


Secondary Outcome Measures :
  1. Antibody titer 1:40 or more [ Time Frame: 28 days after the last dose of vaccination ]
    Proportion of subjects with antibody titer ≥1:40

  2. Cellular immunity-ELISPOT [ Time Frame: 28 days after the last dose ]
    Quantification by ELISPOT of specific Spot Forming Cells for cytokines, molecules and immunoglobulins induced by both vaccines

  3. Cellular immunity-Cytometry [ Time Frame: 28 days after the last dose ]
    Quantification by flow cytometry of CD3+CD4+ and CD3+CD8+ cells positive for Activation Induced Markers, induced by both vaccines.

  4. Cellular immunity-Luminex (TM) [ Time Frame: 28 days after the last dose ]
    • Quantification by Luminex® of cytokines secreted by specific CD3+CD4+ and CD3+CD8+ cells induced by each vaccine


Other Outcome Measures:
  1. Adverse events (AEs) [ Time Frame: Solicited AEs within 7 days after each dose and unsolicited AEs within 28 days after each dose ]
    Local and systemic AEs

  2. Serious adverse events [ Time Frame: Within 28 days after each dose ]
    Ocurrence and relationship of serious adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Volunteers age 3 years and older, in good health or medically stable;
  2. Written informed consent obtained from subjects or/and legal guardian;
  3. No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study;
  4. Female subjects of non-childbearing may be enrolled in the study. Nonchildbearing 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).

  5. Female subjects of childbearing 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:

  1. History of seasonal influenza within 6 months prior to the study entry;
  2. Axillary temperature ≥37.3℃;
  3. History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
  4. History of allergy to any vaccine, or any ingredient of the experimental vaccine.
  5. Serious adverse reaction(s) to the vaccine, such as urticaria, dyspnea or angioneurotic edema, etc.;
  6. History of serious neurological disorder (such as epilepsy, convulsions, etc.) , or mental illness;
  7. Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
  8. 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;
  9. Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
  10. Absence of spleen, functional absence of spleen, and absence or removal of spleen under any circumstances;
  11. Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
  12. Alcoholism or history of drug abuse
  13. Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  14. Received blood products within 3 months prior to study entry;
  15. 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;
  16. Pregnant women or lactating women;
  17. Subjects participate other clinical trials (licensed or unlicensed vaccines, drugs, organisms, devices, blood products or drugs) during the study period;

  18. Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494047


Contacts
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Contact: Pablo A Gonzalez, PhD +56226862842 pagonzalez@bio.puc.cl
Contact: Mario A Calvo, MD +56999676538 macalvo@uach.cl

Locations
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Chile
Hospital Puerto Montt Recruiting
Puerto Montt, Los Lagos, Chile
Contact: Loreto I Twele, MD    +56991391703    loreto.twele@gmail.com   
Contact: Pia E Jara    +56957557121    piaelisaj@gmail.com   
Centro de Investigaciones Médicas Respiratorias (CIMER) Recruiting
Providencia, Metropolitana, Chile, 7500657
Contact: Rosa M Feijoo, MD    +56998268855    rmfeijoo@gmail.com   
Contact: Anyelina Navarrete    +56935251586    anyelinanq21@yahoo.es   
Hospital Clínico UC Christus Recruiting
Santiago, Metropolitana, Chile, 8330024
Contact: Alvaro Rojas, MD    56934056808    arojas@med.puc.cl   
Contact: María S Navarrete, RN    56975288431    msnavarr@uc.cl   
Hospital Félix Bulnes Recruiting
Santiago, Metropolitana, Chile, 9110056
Contact: Carlos Pérez, MD    +56998211521    carlos.perez@uss.cl   
Contact: Loreto Pérez, RN    56985959276    perezlor@gmail.com   
Clínica Alemana de Santiago Recruiting
Vitacura, Metropolitana, Chile, 7650567
Contact: Andrea Schilling, MD    56996798671    dra.andrea.schilling@gmail.com   
Contact: Amy Riviotta, RN    56998186942    ariviotta@udd.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Sinovac Biotech (Chile) SpA
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Pablo A Gonzalez, PhD Pontifical Catholic University of Chile
More Information
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Publications:

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT05494047    
Other Study ID Numbers: PRO-QINF-3004
First Posted: August 9, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
influenza
vaccine
immunogenicity
clinical-trial
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs