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AzTrials

Seasonal InfluenzaPhase 4NCT05512494

Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

A Phase 4 study testing Quadrivalent Influenza Vaccine (Split Virion), inactivated in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.

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

This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion)… Read more about this study

Who is it for?
Ages 9 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Seasonal Influenza
What is being tested?
Quadrivalent Influenza Vaccine (Split Virion), inactivated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
1 siteChina
Study dates
27 Nov 2022to 24 Jan 2023
Phase
Phase 4
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 9 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy subjects aged 9-59 years;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 9-17 years, both subjects and guardians need to sign the informed consent form).
  • Proven legal identity.

Who cannot join

  • Received seasonal influenza vaccine for 2022-2023 influenza season, or had an influenza vaccine schedule during the study;
  • Suffering from seasonal influenza in the past 6 moths;
  • Women of childbearing age (menarche to premenopause) are pregnant(including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
  • Patients with fever on the day of vaccination,underarm body temperature>37.2 ℃;
  • History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
Show all 19Show fewer
  • Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Autoimmune disease or immune deficiency/immunosuppression;
  • Thyroid disease or history of thyroidectomy,absence of spleen, functional functional asplenia,and absence of spleen or splenectomy as a result of any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • A long history of alcohol or drug abuse;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
  • Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days,receipt of inactivated or subunit vaccines in the past 7 days;
  • The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials during the follow-up period;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yuping Dong Autonomous County Center for Disease Control and Prevention

    Zhumadian, Guizhou, 554099

Other trials in China

About this study

Official title: A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old

This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old.

Read the detailed description

This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59 years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and 900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial scale,respectively.

Being tested
Quadrivalent Influenza Vaccine (Split Virion), inactivated

What participants receive

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

  • Quadrivalent Influenza Vaccine (Split Virion), inactivatedBiological

    The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. The four influenza strains（including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.

Study groups in NCT05512494
Study groupRoleWhat they receive
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1Experimental420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 1.
Receives: Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2Experimental420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 2.
Receives: Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3Experimental420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 3.
Receives: Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated

What is being measured

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

  1. Immunogenicity index of GMT

    GMT of HI antibodies of each influenza strain at 28 days after vaccination.

    Measured: 28 days after vaccination

Secondary outcomes (7)

  1. Immunogenicity index of seroconversion rate

    Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination.

    Measured: 28 days after vaccination

  2. Immunogenicity index of protection rate

    Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).

    Measured: 28 days after vaccination

  3. Immunogenicity index of GMI

    GMI of HI antibodies of each influenza strain at 28 days after vaccination.

    Measured: 28 days after vaccination

  4. Safety index of the incidence of adverse reactions

    Incidence of adverse reactions from 0 to 28 days after vaccination.

    Measured: From 0 to 28 days after vaccination.

  5. Safety index -The incidence of adverse reactions

    Incidence of adverse reactions from 0 to 7 days after vaccination.

    Measured: From 0 to 7 days after vaccination.

  6. Safety index of the incidence of serious adverse events

    Incidence of serious adverse events from 0 to 28 days after vaccination.

    Measured: From 0 to 28 days after vaccination

  7. Safety index of incidence of adverse events

    Incidence of adverse events of special concern from 0 to 28 days after vaccination.

    Measured: From 0 to 28 days after vaccination

Timeline

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

  1. First posted23 Aug 2022
  2. Study start27 Nov 2022
  3. Primary completion24 Jan 2023
  4. Study completion24 Jan 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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05512494
Sponsor's protocol ID
PRO-QINF-4003
Status last verified
Jul 2022
First submitted
21 Aug 2022
Last updated
18 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gao Y, Yang X, Li X, Chen H, Li Y, Tan X, Yu D, Feng T, Zhou S, Lei S, Zhao C, Wang J, Guan Q. Lot-to-lot consistency, immunogenicity and safety of a quadrivalent split virion inactivated influenza vaccine in healthy population aged 9-59 years: A randomized, double-blind, controlled, phase IV clinical trial. Vaccine. 2024 Aug 30;42(21):126182. doi: 10.1016/j.vaccine.2024.126182. Epub 2024 Aug 6.

    PubMed 39116486

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quadrivalent Influenza Vaccine (Split Virion), inactivated in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.

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 3 inclusion and 19 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Immunogenicity index of GMT (time frame: 28 days after vaccination). 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 NCT05512494, which also lists 1 linked publication.

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 18 Sep 2023.

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