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    Summary
    EudraCT Number:2015-005482-23
    Sponsor's Protocol Code Number:INFQ3002
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-02
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2015-005482-23
    A.3Full title of the trial
    Randomized, Double-Blind and Active-Controlled Study in Children and Adolescents Aged 3–17 Years to Assess the Safety and Immunogenicity of Abbott’s Candidate Quadrivalent Influenza Vaccine and its Non-Inferiority versus Trivalent Influenza Vaccine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A blinded study to compare the safety and immune response in children and adolescents aged 3-17 years between Abbott's Candidate Quadrivalant Influenza and Trivalent Influenza Vaccine.
    A.4.1Sponsor's protocol code numberINFQ3002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/182/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbott Biologicals B.V.
    B.1.3.4CountryNetherlands
    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 supportAbbott Biologicals B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Biologicals B.V.
    B.5.2Functional name of contact pointGlobal Clinical Director
    B.5.3 Address:
    B.5.3.1Street AddressC.J. van Houtenlaan 36
    B.5.3.2Town/ cityWeesp
    B.5.3.3Post code1381 CP
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 294 477184
    B.5.5Fax number+31294 477160
    B.5.6E-mailserge.vandewitte@abbott.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 No
    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.3.1Product nameQuadrivalent Influenza Vaccine
    D.3.2Product code QIV
    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 INNinfluenza vaccine (surface antigen, inactivated)
    D.3.9.2Current sponsor codeQIV
    D.3.9.3Other descriptive namequadrivalent influenza vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Influvac®
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Healthcare GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameInfluvac (Tiv containing B Yamagata strain)
    D.3.2Product code TIV (Yam)
    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 INNInfluenza vaccine (surface antigen, inactivated)
    D.3.9.2Current sponsor codeTIV (Yam)
    D.3.9.3Other descriptive nametrivalent influenza vaccine (Yam)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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.3.1Product nameInfluvac (TIV containing B-Victoria strain)
    D.3.2Product code TIV (Vic)
    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 INNInfluenza vaccine (surface antigen, inactivated)
    D.3.9.2Current sponsor codeTIV (Vic)
    D.3.9.3Other descriptive nametrivalent influenza vaccine (Vic)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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
    E.1.1.1Medical condition in easily understood language
    Prevention of Influenza (flu) Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate in a population of children and adolescents 3 to 17 years of age the non-inferiority of quadrivalent influenza vaccine (QIV) with respect to post-vaccination geometric mean Hemagglutination Inhibition (HI) antibody titers against the shared strains compared with the trivalent influenza vaccines (TIV) with either the B-strain of the Victoria (TIV(Vic)) or the B-strain of the Yamagata lineage (TIV(Yam)).
    E.2.2Secondary objectives of the trial
    1.To demonstrate the superiority of QIV to TIV(Vic) and TIV(Yam)with respect to post-vaccination geometric mean HI antibody titers against the alternate-lineage B strain in a population of children and adolescents 3 to 17 years of age.
    2.To describe the immunogenicity of each of the strains in QIV with respect to HI, Virus Neutralization (VN) and Neuraminidase Inhibition (NI) antibody titers in the study population overall and by subject age, preexisting antibody status and baseline health status.
    3.To describe Cell-Mediated Immunity (CMI) values for a subset of subjects.
    Safety Objective:
    To compare the reactogenicity and safety of QIV with that of TIV in a population of children and adolescents 3 to 17 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female children and adolescents 3 to 17 years of age at the time of enrolment in stable health determined from medical history, physical examination and clinical judgment of the Investigator. Subjects may have underlying illnesses as long as their symptoms/signs are controlled.
    •The subject’s parent(s) or LAR(s) sign and date a written, informed consent form (ICF). An assent will also be obtained according to age appropriate country-specific regulations.
    •Subject and parent(s) or LAR(s) are able and willing to attend all scheduled visits and to comply with all trial procedures.
    E.4Principal exclusion criteria
    1.Child in care (as defined in the protocol)
    2.History of allergy to egg, chicken proteins, or history of any reaction or hypersensitivity to a previous dose of influenza vaccine components.
    3.History of serious adverse reaction to any influenza vaccine.
    4.History of Guillain-Barré syndrome.
    5.History of seizures (subject who had a single uncomplicated febrile convulsion in the past could be included) or progressive neurological disease.
    6.Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
    7.Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) or laboratory-confirmed influenza infection in the 6 months preceding the first study vaccination.
    8.Receipt of any vaccine (including routine childhood vaccines) within the preceding 30 days or planned vaccination during the study within 30 days after any study vaccine administration.
    9.Having fever and/or acute disease or infection on the day of first study vaccination (enrolment can be deferred for up to 2 weeks provided subject remains otherwise eligible).
    10.Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding enrolment.
    11.Chronic systemic administration (defined as more than 14 days) of immunosuppressant or immune-modifying medication (such as corticosteroids and monoclonal antibodies) during 3 months prior to the first study vaccination or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
    12. Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine including (but not limited to) bleeding disorder, acute or progressive clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and/or physical examination.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint concerns the geometric mean HI antibody titers against the 4 vaccine strains
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after study vaccination (Day 29, primed subjects) or 28 days after the second study vaccination (Day 57, unprimed subjects).
    E.5.2Secondary end point(s)
    The secondary endpoints concern:
    1)Change from baseline geometric mean HI antibody titers against the 4 vaccine strains.
    2)Post-vaccination geometric mean VN and NI antibody titers and change from baseline against the 4 vaccine strains for a randomized subset of subjects.
    3)Seroconversion rates and geometric mean fold increases for HI, VN and NI for the 4 vaccine strains for a randomized subset of subjects.
    4)Post-vaccination CMI values for a subset of subjects and change from baseline.
    Safety points:
    1)All unsolicited (spontaneously reported) AEs
    2)SAEs, AESIs and NCIs
    3) Solicited injection site reactions and systemic reactions
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)2)3)4: Day 29 for primed subjects
    Day 57 for unprimed subjects

    For Safety points:
    1) From ICF signature to Day 29 (primed subjects) or Day 57 (unprimed subjects)
    2) from ICF signature to final follow-up telephone call approximately 6 months later (Day 183)
    3) within 7 days following each study vaccination.
    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 Yes
    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 and reactogenicity
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS (last visit is the safety follow up phone contact at Day 183)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 1200
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 900
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    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 Yes
    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
    minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state460
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1200
    F.4.2.2In the whole clinical trial 1200
    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)
    N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-14
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