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    Summary
    EudraCT Number:2016-004904-74
    Sponsor's Protocol Code Number:INFQ3003
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-16
    Trial 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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2016-004904-74
    A.3Full title of the trial
    A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine.
    Randomizované, mezinárodní klinické hodnocení fáze III s paralelními skupinami, zaslepené vůči hodnotiteli a kontrolované srovnávací nechřipkovou vakcínou u dětí ve věku 6 až 35 měsíců posuzující bezpečnost a účinnost kandidátní kvadrivalentní vakcíny proti chřipce společnosti Abbott
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the safety and efficacy of Abbott's Quadrivalent Influenza Vaccine versus a non-influenza vaccine in children aged 6-35 Months
    A.4.1Sponsor's protocol code numberINFQ3003
    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 Healthcare Products B.V.
    B.5.2Functional name of contact pointGlobal Clinical Director Vaccines
    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 nameQIV (Quadrivalent Influenza Vaccine)
    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 (Quadrivalent 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 Prevenar 13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    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 INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED)
    D.3.9.3Other descriptive namePneumococcal conjugated vaccine
    D.3.9.4EV Substance CodeSUB181170
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.2 to 4.4
    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 Yes
    D.2.1.1.1Trade name Menjugate
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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
    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 INNMeningococcal group C conjugate vaccine
    D.3.9.3Other descriptive nameMeningococcal group C conjugate vaccine
    D.3.9.4EV Substance CodeSUB26074
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 4
    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 TicoVac Junior, FSME-IMMUN Junior
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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
    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 INNTickborne encephalitis vaccine
    D.3.9.3Other descriptive nameTICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN
    D.3.9.4EV Substance CodeSUB26470
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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: 5
    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 Havrix Junior
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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
    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 INNHepatitis A vaccine
    D.3.9.3Other descriptive nameHEPATITIS A VIRUS (INACTIVATED)
    D.3.9.4EV Substance CodeSUB20081
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit enzyme-linked immunosorbent assay unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720
    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: 6
    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 Varivax, Provarivax
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Powder and solvent for suspension for injection
    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 INN• Varicella vaccine
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
    D.3.9.4EV Substance CodeSUB25312
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1350
    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 20.0
    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 children 6-35 months of age the absolute efficacy of QIV in the prevention of symptomatic influenza infection due to any circulating seasonal influenza strain compared to a non-influenza vaccine.
    E.2.2Secondary objectives of the trial
    -Demonstrate the absolute efficacy of QIV in the prevention of symptomatic influenza infection of antigenically-matching influenza strains compared to a non-influenza vaccine
    -Describe the immunogenicity of each of the strains in QIV with respect to HI in all subjects and VN and NI antibody titers in randomized population subsets.
    -Describe CMI for a subset of subjects at selected sites
    -Describe Year 2 baseline and post-vaccination immunogenicity for each of the strains in QIV with respect to HI in all subjects and NI and VN in random population subsets of subjects exposed to QIV in Year 1 and who will receive revaccination
    -Evaluate the occurrence of all-cause mortality, hospitalization, ILIs, all-cause pneumonia and otitis media in the QIV group compared with the non-influenza vaccine control groups
    -Explore potential immunological correlates of protection based on determined HI antibody titers and RT-PCR outcomes
    -Evaluate healthcare utilization and health economic outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female subjects between, and including, 6 and 35 months* of age at Day 1 and in stable health as judged by medical history, physical examination and clinical judgment of the Investigator. Subjects may have underlying chronic disorders as long as their symptoms/signs are controlled and yearly (seasonal) influenza vaccination is not recommended as a result of the underlying condition. If at the time of enrolment the subject has been on medication for a pre-existing condition, the dose must have been stable for at least three months.
    2.Subjects who are 6-24 months of age at Day 1 should have been born at full term of pregnancy (≥ 37 weeks gestation) and with a birth weight of ≥ 2.5 kg.
    3.Written informed consent obtained from the parent(s)/LAR(s) of the subject.
    4.Subject and parent or other legally acceptable representative are able and willing to attend all scheduled visits and to comply with all trial procedures.
    * The age range for enrollment may be restricted at a country/region/site level if none of the non-influenza control vaccines can be used in one or more age groups.
    E.4Principal exclusion criteria
    1.Child in care
    2.History of allergy to egg, chicken proteins, or other vaccine components.
    3.History of serious adverse reaction to any vaccine.
    4.History of Guillain-Barré syndrome.
    5.Chronic administration (defined as more than 14 days) of immunosuppressants or other immune modifying medication within three months prior to the first vaccine dose 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.
    6.Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
    7.Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy.
    8.Any confirmed or suspected immunosuppressive or immunodeficient condition (including human immunodeficiency virus [HIV]), based on medical history and physical examination.
    9.Being a solid organ or bone marrow/stem cell transplant recipient.
    10.Ongoing aspirin therapy (to avoid cases of Reye’s syndrome).
    11.Receipt of an influenza vaccine ever before or having been diagnosed with influenza (confirmed by laboratory or rapid influenza diagnostic tests) ever before.
    12.Receipt of any vaccine (including routine childhood vaccines) within 28 days prior to study vaccination or planned vaccination within 28 days following each study vaccination.
    13.Planned administration of any influenza vaccine (other than the study vaccination) during the entire study period.
    14.Children with underlying illness who are at risk of complications of influenza and children for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
    15.Having fever and/or an acute disease or infection on the day of first study vaccination. Fever is defined as a body temperature ≥ 38.0oC measured rectally (preferred method) or anxillary ≥ 37.5 oC (if rectal method is not possible, e.g. because of medical reason).
    16.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, immunodeficiency, seizure disorder, acute or progressive hepatic, renal, neurological or neuromuscular disease.
    17.Participation in the study prevents the receipt of scheduled routine childhood vaccinations or leads to deviations from recommended vaccination schedule which would have a medical impact.

    Addtional exlcusion criteria described in the Protocol section 5.2 would apply for non-influenza vaccines
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: First occurrence of reverse transcription RT-PCR confirmed influenza A and/or B illness of any severity due to any circulating seasonal influenza strain
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between 28 days following the second vaccine administration and the end of the influenza surveillance period.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints concern:
    1.First occurrence of cell culture-confirmed influenza A and/or B illness of any severity due to antigenically-matching influenza strains occurring between 28 days following the second vaccine administration and the end of the influenza surveillance period.
    2.All-cause mortality, hospitalization, ILIs, all-cause pneumonia and otitis media.
    3.Post-vaccination geometric mean HI (all subjects), VN and NI antibody (random population subsets) titers and change from baseline against the four vaccine strains.
    4.Seroconversion rates and geometric mean fold increases for HI (all subjects), VN and NI (randomized sample) for the four vaccine strains.
    5.Post-vaccination CMI values and change from baseline for a subset of subjects at selected sites.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Between 28 days following the second vaccine administration and the end of the influenza surveillance period.
    Others: As soon as these occur

    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
    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 Yes
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Czech Republic
    Denmark
    Estonia
    Hungary
    Italy
    Lithuania
    Romania
    Slovakia
    Slovenia
    Spain
    Sweden
    Ukraine
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 2000
    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: 1500
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 500
    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
    minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state410
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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 Decision2017-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
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