Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002785-13
    Sponsor's Protocol Code Number:V130_10
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-12-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2020-002785-13
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to
    Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit
    Influenza Virus Vaccine (QIVc) and a United States-licensed Quadrivalent
    Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
    A.4.1Sponsor's protocol code numberV130_10
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/084/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSeqirus Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSeqirus Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeqirus Inc.
    B.5.2Functional name of contact pointClinical Trial Disclosure Manager
    B.5.3 Address:
    B.5.3.1Street Address475 Green Oaks Parkway
    B.5.3.2Town/ cityHolly Springs
    B.5.3.3Post codeNC 27540
    B.5.3.4CountryUnited States
    B.5.6E-mailSeqirus.Clinicaltrials@seqirus.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name QIVc (Flucelvax Quadrivalent)
    D.2.1.1.2Name of the Marketing Authorisation holderSeqirus Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/(H1N1)-LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameA/(H1N1)-LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117552
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/(H3N2)-LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameA/(H3N2)-LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117553
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/– Like Virus Antigen (Victoria Lineage)
    D.3.9.3Other descriptive nameB/– Like Virus Antigen (Victoria Lineage)
    D.3.9.4EV Substance CodeSUB117554
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/– Like Virus Antigen (Yamagata Lineage)
    D.3.9.3Other descriptive nameB/– Like Virus Antigen (Yamagata Lineage)
    D.3.9.4EV Substance CodeSUB117554
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis of Influenza Virus Infection
    E.1.1.1Medical condition in easily understood language
    Seasonal Influenza
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PRIMARY IMMUNOGENICITY OBJECTIVE: To demonstrate that vaccination with QIVc elicits an immune response that is not inferior to that of a US-licensed QIV containing the recommended strains for the season, in subjects 6 months through 47 months of age, as measured by hemagglutination inhibition (HAI) assay for A/H1N1, B/Yamagata and B/Victoria strains and by microneutralization (MN) assay for A/H3N2 strain, using cell-derived target viruses.
    E.2.2Secondary objectives of the trial
    SECONDARY IMMUNOGENICITY OBJECTIVES:
    1. To describe the immunogenicity of QIVc and US-licensed QIV by HAI assay for A/H1N1, B/Victoria, and B/Yamagata strains, and by MN assay for A/H3N2 strain, using egg-derived target viruses.
    2. To describe the immunogenicity of QIVc and US-licensed QIV by HAI assay for A/H1N1, B/Victoria, and B/Yamagata strains, and by MN assay for A/H3N2 strain, using cell-derived target viruses.
    3. To describe the immunogenicity of QIVc and US-licensed QIV by MN assay for A/H1N1, B/Victoria, and B/Yamagata strains, in a subset of subjects.

    SECONDARY SAFETY OBJECTIVE:
    1. To evaluate the safety and reactogenicity of QIVc and US-licensed QIV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Individuals 6 through 47 months of age on the day of informed consent.
    2. Individuals whose parent(s)/ LAR(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
    3. Individuals who can comply with study procedures, including follow-up1.
    4. Individual who is in generally good health as per the Investigator’s medical judgement.
    E.4Principal exclusion criteria
    1. Acute (severe) febrile illness.
    2. History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
    3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
    4. A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
    5. Abnormal function of the immune system resulting from clinical conditions, which include:
    a. Known or suspected congenital or acquired immunodeficiency.
    b. Systemic administration of corticosteroids (PO/IV/IM) at any dose for more than 14 days, within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (1 dose in 30 days) of intra-articular corticosteroids is also permitted.
    c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
    6. Received immunoglobulins or any blood products within 180 days prior to informed consent.
    7. Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or intend to participate in another clinical trial during the study.
    8. Study personnel, family and household members of study personnel should not participate.
    9. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
    10. Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
    11. Received any other vaccines than influenza vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to study vaccination or who are planning to receive any vaccine within 28 days after study vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Immunogenicity Endpoints: Serum antibody titers against A/H1N1, B/Victoria and B/Yamagata vaccine strains by HAI assay and serum neutralizing antibody titers against A/H3N2 vaccine strain by MN assay at Day 1 and Day 29/57 using cell-derived target virus strains.
    The noninferiority of QIVc compared to US-licensed QIV will be assessed for the eight co-primary endpoints of geometric mean titer (GMT) and seroconversion rate (SCR) for each cell-derived target virus strain included in QIVc as follows:
    - The GMT ratio for the A/H1N1 strain (HAI assay)
    - The GMT ratio for the A/H3N2 strain (MN assay)
    - The GMT ratio for the B Yamagata strain (HAI assay)
    - The GMT ratio for the B Victoria strain (HAI assay)
    - The difference between the SCRs for the A/H1N1 strain (HAI assay)
    - The difference between the SCRs for the A/H3N2 strain (MN assay)
    - The difference between the SCRs for the B Yamagata strain (HAI assay)
    - The difference between the SCRs for the B Victoria strain (HAI assay)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immunogenicity of study vaccines will be evaluated at Day 1 and Day 29 for “previously
    vaccinated” subjects or Day 1 and Day 57 for “not previously vaccinated” subjects.
    HAI antibody responses will be evaluated for A/H1N1 and both B strains, and
    neutralizing antibody responses will be evaluated for the A/H3N2 strain in the
    immunogenicity group of subjects (primary immunogencity evaluation). Recent
    evolutionary changes in A/H3N2 hemagglutinin have resulted in the loss of capacity to
    agglutinate, and therefore the two A/H3N2 endpoints will be assessed using the MN assay.
    Cell-derived target virus data will be used for the primary immunogenicity analysis in
    both assays.
    E.5.2Secondary end point(s)
    Secondary Immunogenicity Endpoints:
    #1 Humoral immune response in terms of HAI antibodies against A/H1N1, B/Victoria and B/Yamagata strains, using cell- and egg-derived target virus:
    - GMT by HAI assay at Days 1 and 29/57
    - Geometric Mean Ratio (GMR), defined as the fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1)
    - Seropositivity rates (percentages of subjects with HAI titer ≥1:10) at Days 1 and 29/57
    - Percentages of subjects with HAI titer ≥1:40 at Days 1 and 29/57
    - SCR by HAI assay

    #2 Neutralizing antibody titers against A/H3N2 vaccine strains, using cell- and egg-derived target virus:
    • GMT by MN assay at Days 1 and 29/57
    • GMR, defined as the fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1)
    • Seropositivity rates (percentages of subjects with MN titer ≥ 1:10 (LLOQ)) at Days 1 and 29/57
    • SCR by MN assay, where SCR for MN is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 (LLOQ)) and a ≥4-fold increase in post vaccination MN titer

    #2 Neutralizing antibody titers against A/H1N1, B/Victoria and B/Yamagata vaccine strains, in a subset of subjects:
    • GMT by MN assay at Days 1 and 29/57
    • GMR, defined as the fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1)
    • Seropositivity rates (percentages of subjects with MN titer ≥1:10 (LLOQ)) at Days 1 and 29/57
    • SCR by MN assay


    Secondary Safety Endpoints: the measures for assessing safety and reactogenicity are as follows:
    1. Percentage of subjects with solicited AEs within 7 days after each study vaccination
    2. Percentage of subjects with any unsolicited AEs from Day 1 to Day 29 (in previously vaccinated subjects) and from Day 1 to Day 57 (in not previously vaccinated subjects)
    3. Percentage of subjects with any SAEs, NOCDs, AEs leading to withdrawal during the entire study period (ie, from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation for the secondary immunogenicity endpoints are Day 1 and Day 29/57, the latter depending upon age and previous influenza vaccine history.
    For the secondary immunogenicity evaluation, HAI antibody responses will be evaluated
    in the immunogenicity group of subjects for A/H1N1 and both B strains, and neutralizing
    antibody responses will be evaluated for A/H3N2 strains, using egg- and cell-derived
    target virus in both assays.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-Blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Egg-based quadrivalent inactivated influenza virus vaccine
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For the purpose of this protocol, end of study is defined as the completion of the Last Subject Last Visit (LSLV),
    ie, the last subject’s Day 181 or Day 209 safety assessment call, or the completion of
    testing of biological samples to be achieved no later than 8 months after LSLV,
    whichever is longer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2414
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 902
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1512
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects are children aged 6 through 47 months . Written informed consent will be obtained from parent(s) or legally acceptable representative(s) of the subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2414
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Study has a treatment period and a follow-up period. The treatment period has scheduled visits planned depending on the subject’s influenza vaccination history and age of the subject and ends 28 days after last vaccination. The follow-up period will conclude with a study completion call (study completion call will be 180 days after last vaccination)
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 05:18:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA