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

August 7, 2022 updated by: Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • 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 Backup

  • Name: Mario A Calvo, MD
  • Phone Number: +56999676538
  • Email: macalvo@uach.cl

Study Locations

  • Chile
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile
    • Metropolitana
      • Providencia, Metropolitana, Chile, 7500657
        • Recruiting
        • Centro de Investigaciones Médicas Respiratorias (CIMER)
        • Contact:
        • Contact:
      • Santiago, Metropolitana, Chile, 8330024
        • Recruiting
        • Hospital Clínico UC Christus
        • Contact:
        • Contact:
          • María S Navarrete, RN
          • Phone Number: 56975288431
          • Email: msnavarr@uc.cl
      • Santiago, Metropolitana, Chile, 9110056
        • Recruiting
        • Hospital Felix Bulnes
        • Contact:
        • Contact:
      • Vitacura, Metropolitana, Chile, 7650567

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

Ages Eligible for Study

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

    -

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sinovac vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days after the last dose of vaccination

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Solicited AEs within 7 days after each dose and unsolicited AEs within 28 days after each dose
Serious adverse events
Time Frame: Within 28 days after each dose
Ocurrence and relationship of serious adverse events
Within 28 days after each dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Sinovac Biotech Co., Ltd
Sinovac Biotech (Chile) SpA

Investigators

  • Principal Investigator: Pablo A Gonzalez, PhD, Pontifical Catholic University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 14, 2022

Primary Completion (ANTICIPATED)

May 31, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

August 7, 2022

First Submitted That Met QC Criteria

August 7, 2022

First Posted (ACTUAL)

August 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 7, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-QINF-3004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Influenza

Clinical Trials on Tetravalent influenza vaccine developed by Sinovac Biotech Co.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe