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Seasonal InfluenzaPhase 3NCT03853993

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

A Phase 3 study testing Quadrivalent influenza vaccine, Trivalent influenza vaccine (contains B/Victoria strain) and Trivalent influenza vaccine (contains B/Yamagata strain) in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 2 sites 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

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years 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?
Quadrivalent influenza vaccine, Trivalent influenza vaccine (contains B/Victoria strain) and Trivalent influenza vaccine (contains B/Yamagata strain)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,380 participants
Where
2 sitesChina
Study dates
23 Jan 2018to 8 Oct 2018
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

  • Healthy volunteers aged ≥3 years;
  • Proven legal identity;
  • Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;

Who cannot join

  • Prior vaccination with influenza vaccine of the current year;
  • History of influenza within 6 months prior to study entry;
  • Axillary temperature > 37.0 °C;
  • History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
  • Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
  • Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
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  • Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
  • History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
  • No spleen, or functional no spleen, or splenectomy.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Guanyun Center for Disease Control and Prevention

    Lianyungang, Jiangsu, 222200

  • Pizhou Center for Disease Control and Prevention

    Pizhou, Jiangsu, 221300

Other trials in China

About this study

Official title: Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged Over 3 Years.

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

Read the detailed description

This study is a phase I\& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd.

Being tested
Quadrivalent influenza vaccine, Trivalent influenza vaccine (contains B/Victoria strain), Trivalent influenza vaccine (contains B/Yamagata strain)
Keywords
Influenza Vaccine, Quadrivalent, Trivalent
Medical subject headings
Influenza, Human

What participants receive

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

  • Quadrivalent influenza vaccineBiological

    Received single dose QIV (15µg/0.5ml)

  • Trivalent influenza vaccine (contains B/Victoria strain)Biological

    Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)

  • Trivalent influenza vaccine (contains B/Yamagata strain)Biological

    Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Study groups in NCT03853993
Study groupRoleWhat they receive
Experimental group-phase IExperimentalQuadrivalent influenza vaccine
Receives: Biological: Quadrivalent influenza vaccine
Experimental group-phase IIIExperimentalQuadrivalent influenza vaccine
Receives: Biological: Quadrivalent influenza vaccine
Control group-1-phase IIIActive comparatorTrivalent influenza vaccine (contains B/Victoria strain)
Receives: Biological: Trivalent influenza vaccine (contains B/Victoria strain)
Control group-2-phase IIIActive comparatorTrivalent influenza vaccine (contains B/Yamagata strain)
Receives: Biological: Trivalent influenza vaccine (contains B/Yamagata strain)

What is being measured

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

  1. The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3.

    Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines

    Measured: 28 days after the injection

  2. The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%

    Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines

    Measured: 28 days after the injection

Secondary outcomes (13)

  1. The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .

    Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type

    Measured: 28 days after the injection

  2. The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%

    Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type

    Measured: 28 days after the injection

  3. The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%

    Immunogenicity index

    Measured: 28 days after the injection

  4. The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%

    Immunogenicity index

    Measured: 28 days after the injection

  5. The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%

    Immunogenicity index

    Measured: 28 days after the injection

  6. The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%

    Immunogenicity index

    Measured: 28 days after the injection

  7. The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5

    Immunogenicity index

    Measured: 28 days after the injection

  8. The geometric mean increase (GMI) in the subjects aged over 60 years >2.0

    Immunogenicity index

    Measured: 28 days after the injection

  9. The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40

    Immunogenicity index

    Measured: 28 days after the injection

  10. The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40

    Immunogenicity index

    Measured: 28 days after the injection

  11. The incidence of the solicited local and general adverse reactions on day 0-7

    Safety index, The adverse reactions refers to the adverse events which considered related to the vaccination

    Measured: 0-7 days after the injection

  12. The incidence of the unsolicited adverse events on day 0-28

    Safety Index

    Measured: 0-28 days after the injection

  13. The incidence of the serious adverse events within 6 months after the injection

    Safety Index

    Measured: Within 6 months after the injection

Timeline

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

  1. First posted26 Feb 2019
  2. Study start23 Jan 2018
  3. Primary completion17 Aug 2018
  4. Study completion8 Oct 2018

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
Model description
The phase I clinical trial has single arm, and the phase III clinical trial has 3 parallel arms.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03853993
Sponsor's protocol ID
PRO-QINF-3001
Status last verified
Feb 2019
First submitted
21 Feb 2019
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chu K, Xu K, Tang R, Tian X, Hu J, Yang T, Li C, Hu Y, Zeng G. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged >/=3 years. Vaccine. 2020 Aug 18;38(37):5940-5946. doi: 10.1016/j.vaccine.2020.06.071. Epub 2020 Jul 27.

    PubMed 32732142

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent influenza vaccine, Trivalent influenza vaccine (contains B/Victoria strain) and Trivalent influenza vaccine (contains B/Yamagata strain) in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 2 sites 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 9 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3. (time frame: 28 days after the injection). 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 NCT03853993, 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 27 Feb 2019.

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