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Seasonal InfluenzaPhase 3NCT03859141

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

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 children aged 6-35 months. Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy 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
2,340 participants
Where
2 sitesChina
Study dates
6 Feb 2018to 2 Nov 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 6 to 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy volunteer between 6 - 35 months old; Term birth; Birth weight >2500g;
  • Proven legal identity;
  • Written consent of the guardian(s) of the volunteer;

Who cannot join

  • Received seasonal influenza vaccine in the current year;
  • Suffering from seasonal influenza in the past 6 moths;
  • Axillaty temperature > 37.0 °C;
  • History of allergy to any vaccine or vaccine ingredient;
  • History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
  • Autoimmune disease or immunodeficiency;
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  • Congenital malformation, developmental disorders;
  • Severe malnutrition;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • History of epilepsy (except febrile seizures occurred < 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment)
  • Chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders)
  • Acute disease or acute stage of chronic disease;
  • Receipt of any of the following products:
  • Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;
  • Any live attenuated vaccine within 30 days prior to study entry;
  • Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
  • Blood product within 3 months prior to study entry;
  • Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
  • Participate or will participate in other clinical trial(s) during this study;
  • Based on the judgment of investigator(s) or the Ethic Committee, there was any condition indicating that the subject should be excluded;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Guanyun Center for Disease Prevention and Control

    Lianyungang, Jiangsu, 222200

  • Pizhou Center for Disease Prevention and Control

    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 6-35 Months

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Read the detailed description

The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were 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, Children
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

    One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

  • Quadrivalent influenza vaccineBiological

    One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

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

    One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.

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

    One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.

Study groups in NCT03859141
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 geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3.

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

    Measured: 28 days after two doses immunization

  2. The lower limit of 95% CI of the seroconversion rate difference (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 two doses immunization

Secondary outcomes (10)

  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 two doses immunization

  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 two doses immunization

  3. The lower limit of 95% CI of seroconversion rate for each HI antibody after two doses immunization≥40%.

    Immunogenicity index

    Measured: 28 days after two doses immunization

  4. The seroprotective rate (HI antibody titer≥1:40) of each HI antibody after two doses immunization≥70%.

    Immunogenicity index

    Measured: 28 days after two doses immunization

  5. The geometric mean increase (GMI) of each HI antibody after two doses immunization >2.5.

    Immunogenicity index

    Measured: 28 days after two doses immunization

  6. 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 two doses immunization

  7. 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 two doses immunization

  8. The incidence of the solicited local and general adverse reactions 0-7 days after each immunization.

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

    Measured: 0-7 days

  9. The incidence of the unsolicited adverse events 0-28 days after each immunization

    Safety Index

    Measured: 0-28 days after each dose immunization

  10. The incidence of the serious adverse events within 7 months after the first immunization.

    Safety Index

    Measured: Within 7 months after the first dose immunization

Timeline

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

  1. First posted1 Mar 2019
  2. Study start6 Feb 2018
  3. Primary completion17 Apr 2018
  4. Study completion2 Nov 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 was a single arm.The phase Ⅲ was 3 parallel arms.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859141
Sponsor's protocol ID
PRO-QINF-3002
Status last verified
Feb 2019
First submitted
28 Feb 2019
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hu Y, Shao M, Hu Y, Liang Q, Jia N, Chu K, Xu L, Li J, Li C, Zhu F. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China. Hum Vaccin Immunother. 2020 Jul 2;16(7):1691-1698. doi: 10.1080/21645515.2020.1721994. Epub 2020 Apr 29.

    PubMed 32347785

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 20 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 1 Mar 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 geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3. (time frame: 28 days after two doses immunization). 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 NCT03859141, 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 1 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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