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Seasonal InfluenzaPhase 3NCT05431725

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

A Phase 3 study testing Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for
Seasonal Influenza
What is being tested?
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,202 participants
Where
11 sitesin 2 countries
Study dates
18 Jul 2022to 19 Jul 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 18Show fewer
  • 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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Chile7 sites

  • Hospital de Puerto Montt

    Port Montt

  • CIMER Center/Center for Medical Research on Respiratory Diseases

    Santiago

  • Clínica Alemana

    Santiago

  • Hospital Clínico UC-Christus

    Santiago

  • Hospital Felix Bulnes

    Santiago

  • Universidad San Sebastián

    Santiago

  • Clinica Alemana de Valdivia

    Valdivia

Other trials in Chile

Philippines4 sites

  • Las Pinas Doctors Hospital

    Las Piñas, Manila

  • Tropical Disease Foundation Inc

    Makati City, Manila

  • Philippine General Hospital

    Manila

  • San Juan De Dios Hospital

    Pasay, Manila

Other trials in Philippines

About this study

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

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.

Read the 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".

Being tested
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, Control Quadrivalent influenza virus vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza Vaccine (Split Virion), Inactivated, QuadrivalentBiological

    Also called Sinovac-QIV

    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.

  • Control Quadrivalent influenza virus vaccineBiological

    Also called Vaxigrip Tetra-QIV

    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.

Study groups in NCT05431725
Study groupRoleWhat they receive
Sinovac-QIV groupExperimental800 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.
Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Vaxigrip Tetra-QIV groupActive comparator800 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.
Receives: Biological: Control Quadrivalent influenza virus vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion rates of HI antibody

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

    Measured: At day 28 after the last dose

  2. GMTs of HI antibody

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

    Measured: At day 28 after the last dose

Secondary outcomes (6)

  1. Seroprotection rates(SCRs) of HI antibody

    Proportion of subjects with antibody titer ≥1:40 at day 28 after the last dose

    Measured: At day 28 after the last dose

  2. Seroconversion rates (SCRs) of HI antibody

    Seroconversion rates at day 28 after the last dose.

    Measured: At day 28 after the last dose

  3. 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.

    Measured: Within 7 days after each dose

  4. Unsolicited AEs

    Occurrence, intensity, duration, and relationship of unsolicited AEs within 28 days after each dose.

    Measured: Within 28 days after each dose

  5. Serious adverse events (SAEs)

    Occurrence and relationship of serious adverse events (SAEs) within 28 days after each dose

    Measured: Within 28 days after each dose

  6. Adverse events of special interest (AESI)

    Adverse events of special interest (AESI) within 28 days after each dose

    Measured: Within 28 days after each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start18 Jul 2022
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431725
Sponsor's protocol ID
PRO-QINF-3004
Status last verified
May 2024
First submitted
19 Jun 2022
Last updated
28 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Chile, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rates of HI antibody (time frame: At day 28 after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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