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    Summary
    EudraCT Number:2011-003188-31
    Sponsor's Protocol Code Number:INF-V-A007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003188-31
    A.3Full title of the trial
    A Phase IV, open label study to evaluate the immune response against homogenous and heterogenous circulating strains in elderly subjects after vaccination with Inflexal V
    Uno studio di Fase IV in aperto per valutare la risposta immunitaria a breve e a lungo termine e la protezione CROCIATA dopo il vaccino con Inflexal V adiuvato da viroSOMA in soggetti anziani
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the evaluation of the short-term and long-term response to the anti-flu vaccination Inflexal V in elderly patients
    Studio sulla valutazione della risposta al vaccino anti influenzale Inflexal V a breve e a lungo termine in pazienti anziani
    A.3.2Name or abbreviated title of the trial where available
    CroSSome Study
    Studio CroSSome
    A.4.1Sponsor's protocol code numberINF-V-A007
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCRUCELL SWITZERLAND AG
    B.1.3.4CountrySwitzerland
    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 supportCrucell Switzerland AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCrucell Italy s.r.l
    B.5.2Functional name of contact pointServizio Info Sperimentazione
    B.5.3 Address:
    B.5.3.1Street AddressVia Zambeletti 25
    B.5.3.2Town/ cityBaranzate (MI)
    B.5.3.3Post code20021
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02356762505
    B.5.5Fax number+39 335266835
    B.5.6E-mailrenato.soncini@crucell.it
    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 INFLEXAL V*1SIR C/A 2010-2011
    D.2.1.1.2Name of the Marketing Authorisation holderCRUCELL ITALY Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution 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 INNINFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED, VIROSOME)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    Healthy female and male elderly subjects where influenza vaccination is suggested
    Soggetti anziani di sesso maschile e femminile in buono stato di salute in cui si ritiene idonea la vaccinazione anti-influenzale
    E.1.1.1Medical condition in easily understood language
    Healthy female and male elderly subjects where influenza vaccination is suggested
    Soggetti anziani di sesso maschile e femminile in buono stato di salute in cui si ritiene idonea la vaccinazione anti-influenzale
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    To evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the current WHO recommended strains
    Valutare la risposta immunitaria umorale 3 settimane dopo il vaccino con Inflexal V conformemente ai criteri del Comitato per i medicinali per uso umano (CHMP) in soggetti anziani per i ceppi vaccinali consigliati dall'OMS per il periodo 2011/2012
    E.2.2Secondary objectives of the trial
    To evaluate immunogenicity parameters 6 months after vaccination; To evaluate the cell mediated immune response 3 weeks after influenza vaccination versus baseline; To assess the cross-protection against selected A/H1N1 heterogenous influenza circulating strains 3 weeks after influenza vaccination versus baseline; To assess the safety and tolerability of the 2011/2012-season influenza vaccine Inflexal V.
    Valutare i parametri di immunogenicità 6 mesi dopo il vaccino per i 3 ceppi vaccinali; Valutare la protezione crociata da 4 ceppi selezionati di influenza A/H1N1 eterogenea in circolazione 3 settimane dopo l'influenza rispetto al basale; Valutare la risposta immunitaria mediata dalle cellule 3 settimane dopo il vaccino influenzale rispetto al basale (per il ceppo del vaccino A/H1N1 e un ceppo eterogeneo A/H1N1) per i primi 30 soggetti arruolati; Valutare la sicurezza e la tollerabilità del vaccino influenzale Inflexal V per la stagione 2011/2012
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy female and male adults aged >60 years on the day of enrollment; Written informed consent; Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause).
    Adulti di sesso maschile e femminile sani con più di 60 anni d'età al giorno dell'arruolamento; Consenso informato scritto; Donne con menopausa confermata (il periodo postmenopausale inizia successivamente ai 12 mesi di assenza del ciclo mestruale senza altre cause mediche).
    E.4Principal exclusion criteria
    Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease; Acute febrile illness (≥38.0 °C); Prior vaccination with an influenza vaccine for season 2011/2012; Known hypersensitivity to any vaccine component; Previous history of a serious adverse reaction to influenza vaccine; History of egg protein allergy or severe atopy; Known blood coagulation disorder; Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed); Known immunodeficiency (including leukemia, HIV seropositivity) or cancer; Investigational medicinal product received in the past 3 months (90 days); Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days); Participation in another clinical trial; Employee at the investigational site or relative of the investigator; Anticipated non-compliance with study procedures.
    Esacerbazione acuta di infezione broncopolmonare (tosse, escreto, esiti polmonari) o altre patologie acute; Malattia acuta febbrile (≥38.0 °C); Precedente vaccino con un vaccino influenzale per la stagione 2011/2012; Ipersensibilità nota a uno qualsiasi dei componenti del vaccino; Precedente anamnesi di gravi reazioni avverse al vaccino influenzale; Anamnesi di allergia alla proteina dell'uovo o grave atopia; Disturbo noto a livello di coagulazione del sangue; Somministrazione cronica (superiore a 14 giorni) di immunosoppressori o altri farmaci immunomodulatori nei 6 mesi precedenti il primo dosaggio del vaccino dello studio, compresi corticosteroidi orali in dosaggi ≥0,5 mg/kg/dí prednisolone o equivalente (sono concessi gli steroidi inalati o topici); Immunodeficienza nota (compresa leucemia, sieropositività all'HIV) o tumore; Prodotto medicinale sperimentale somministrato nel corso degli ultimi 3 mesi (90 giorni); Trattamento con immunoglobulina o trasfusioni di sangue ricevute nel corso degli ultimi 3 mesi (90 giorni); Partecipazione a un'altra sperimentazione clinica; Dipendente presso il centro di sperimentazione o parente dello sperimentatore; Non-conformità anticipata con le procedure dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity parameters for hemagglutination inhibition (HI) antibody titers for the 3 vaccine strains 21 days after vaccination according to CHMP criteria. The immunogenicity parameters will be assessed according to the CHMP 'Note for guidance on harmonisation of requirements for influenza vaccines', 1997. Assessments will be done with the HI test in serum (all subjects) against all the 3 strains included in the seasonal vaccine. To confirm immunogenicity, at least one of the following CHMP criteria has to be met for each strain: Seroconversion rate: defined as a ≥4-fold increase in HI antibody titer and a titer of ≥1:40 to be reached in >30% of subjects; Seroprotection rate: defined as an HI antibody titer ≥1:40 to be reached in >60% of subjects; Geometric mean titer (GMT): defined as >2.0-fold increase in the GMT of HI antibodies.
    Parametri di immunogenicità sui titoli anticorpali in termini di inibizione dell'emoagglutinazione (HI) per i 3 ceppi di vaccino 21 giorni dopo il vaccino, conformemente ai criteri CHMP. I parametri di immunogenicità verranno valutati conformemente alla ''Nota-guida sull'armonizzazione dei requisiti per i vaccini influenzali'' del CHMP, 1997. La valutazione verrà eseguita col test HI, test in siero (tutti i soggetti) per tutti i 3 ceppi inclusi nel vaccino stagionale. Per confermare l'immunogenicità, è opportuno che ogni ceppo soddisfi almeno uno dei seguenti criteri CHMP: Tasso di sieroconversione: definito come un aumento ≥ di 4 volte nel titolo anticorpale HI e un titolo di ≥1:40 da raggiungere nel >30% dei pazienti; Tasso di sieroprotezione: definito come un titolo anticorpale HI ≥1:40 da raggiungere nel >60% dei pazienti; Titolo geometrico medio (GMT): definito come un aumento di 2,0 volte nel GMT degli anticorpi HI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 days after the vaccination
    21 giorni dopo il vaccino
    E.5.2Secondary end point(s)
    Immunogenicity parameters for HI antibody titers for the 3 vaccine strains 6 months after vaccination according to CHMP criteria. The immune response against the A/H1N1 vaccine strain and 4 selected circulating heterogeneous A/H1N1 influenza strains will be assessed with the HI test as well with the microneutralization method to measure the neutralizing influenza antibodies 3 weeks after vaccination versus baseline. A microneutralization and HI titre of 1:40 or more will be considered protective; Cellular immunity will be evaluated for the first 30 enrolled subjects. The following 2 types of cytokines for two influenza strains (the A/H1N1 vaccine strain and one A/H1N1 heterogeneous strain) will be evaluated for cellular immunity 3 weeks after vaccination versus baseline in order to test the impact of vaccination on T-lymphocyte proliferation: o influenza specific IFN gamma production o influenza specific IL-2 production; Solicited local and systemic adverse events (AEs); Unsolicited AEs; Tolerability and acceptability.
    Parametri di immunogenicità sui titoli anticorpali HI per i 3 ceppi di vaccino 6 mesi dopo il vaccino, conformemente ai criteri CHMP; La riposta immunitaria del ceppo vaccinale A/H1N1 e l'eterogeneità dei 4 ceppi influenzali isolati A/H1N1 in circolo sarà valutata tramite test HI, oltre che col metodo della microneutralizzazione, al fine di misurare, rispetto al basale, gli anticorpi che neutralizzano l'influenza 3 settimane dopo il vaccino. Una microneutralizzazione e un titolo HI di 1:40 o più verranno considerati protettivi. L'immunità cellulare verrà valutata per i primi 30 soggetti arruolati. La valutazione rispetto al basale relativa all'immunità cellulare dei seguenti 2 tipi di citochine (il ceppo vaccinale A/H1N1 e un ceppo eterogeneo A/H1N1) sarà effettuata 3 settimane dopo il vaccino, al fine di testare l'impatto del vaccino sulla proliferazione del linfocita T: o produzione di interferone gamma specifico per l'influenza o produzione di IL-2 specifico per l'influenza; Eventi avversi (AEs) sollecitati locali e sistemici; Eventi avversi non sollecitati; Tollerabilità e accettabilità.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity test: 6 months after the vaccination. Cross-reactivity:3 weeks and 6 months (for the 3 vaccine strains only)after vaccination cellular immunity: 3 weeks after the vaccination.
    test di immunogenicità:6 mesi dopo il vaccino. Reazione crociata: 3 settimane e 6 mesi (per i 3 ceppi virali solamente)dopo la vaccinazione immunità cellulare: 3 settimane dopo il vaccino.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    No plan for treatment after a subject has ended his/her participation in the trial
    Non previsto alcun programma di trattamento al termine della partecipazione allo studio
    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 Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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