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    Summary
    EudraCT Number:2014-004515-37
    Sponsor's Protocol Code Number:V87P5
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-10-21
    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 number2014-004515-37
    A.3Full title of the trial
    A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of Fluad-H5N1 and Seasonal Influenza Vaccine in Adult Subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study, performed over a period of approximately 20 months,
    at one study site in Colombia in a population of subjects 18 to 40 years of age. Its aim was to evaluate the immunogenicity, safety and tolerability of H5N1
    adjuvanted vaccine given either sequentially, concomitantly or using
    extemporaneous mixing with a seasonal trivalent influenza vaccine (Agrippal).
    A.3.2Name or abbreviated title of the trial where available
    V87P5
    A.4.1Sponsor's protocol code numberV87P5
    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 SponsorNovartis Vaccines and Diagnostics
    B.1.3.4CountryItaly
    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 supportNovartis Vaccines and Diagnostics
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina 1
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.6E-mailRegistryContactVaccinesUS@novartis.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 nameFluad-H5N1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 Agrippal
    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.3.11 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
    Influenza
    E.1.1.1Medical condition in easily understood language
    Influenza is an acute respiratory disease at high impact on public health
    worldwide. It has high morbidity rates for people of all ages including
    children.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 magnitude of antibody responses to two or three doses of Fluad-H5N1 (H5N1 adjuvanted) influenza vaccine and seasonal Agrippal.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety of the administration of two or three 0.5 mL intramuscular (IM) vaccination of Fluad-H5N1 (H5N1 adjuvanted) influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal Agrippal.
    2. To evaluate the kinetics of antibody responses to one booster dose of Fluad-H5N1 (H5N1 adjuvanted vaccine) mixed extemporaneously with seasonal Agrippal when given 12 months after the first or second dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects aged 18 to 40 years of age who were mentally competent and who signed an informed consent form after having received a detailed explanation of the study protocol;
    2. Subjects who were in good health as determined by:
    ▫ Medical history,
    ▫ Physical examination,
    ▫ Clinical judgment of the Investigator;
    3. Subjects who were able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits;
    E.4Principal exclusion criteria
    1. Who received another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and were unwilling to refuse participation in another clinical study through the end of the study;
    2. Who received influenza vaccination for current season 2007;
    3. Who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy within the past 7 days;
    4. Who experienced fever (defined as axillary temperature ≥38.0°C) within 3 days prior to Visit 1;
    5. Who were Pregnant or breastfeeding;
    6. Females who refused to use an acceptable method of birth control for the duration of the study.
    7. Who had any serious disease, such as:
    a. Cancer,
    b. Autoimmune disease (including rheumatoid arthritis),
    c. Diabetes mellitus,
    d. Chronic pulmonary disease,
    e. Acute or progressive hepatic disease,
    f. Acute or progressive renal disease;
    8. Who had surgery planned during the study period;
    9. Who had bleeding diathesis;
    10. Who had hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
    11. Who had history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
    12. Who had known or suspected impairment/alteration of immune function, for
    example, resulting from:
    a. Receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
    chemotherapy),
    b. Receipt of immunostimulants,
    c. High risk for developing an immunocompromising disease;
    13. Who had received another vaccine within 3 weeks prior and following each study vaccination;
    14. Who had history of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
    15. Who had any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of Subjects Who Responded to Two or Three Vaccinations of the Fluad-H5N1 Influenza Vaccine.
    2. Geometric Mean Ratio After Two or Three Vaccinations of the Fluad-H5N1 Influenza Vaccine.
    3. Number of Subjects Who Responded to Two Vaccinations of the Seasonal Agrippal (Strain H1N1).
    4. Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal Agrippal (Strain H3N2).
    5. Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal Agrippal (Strain B).
    6. Geometric Mean Ratio After Two Doses of the Seasonal Agrippal (Strain H1N1).
    7. Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal Agrippal (Strain H3N1).
    8. Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal Agrippal (Strain B).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 21 days after second and third vaccinations (day 43 and day 403).
    2. 21 days after second and third vaccinations (day 22 and day 43).
    3. 21 days after second vaccination (day 43).
    4. 21 days after second and third vaccinations (day 43 and day 403).
    5. 21 days after second and third vaccinations (day 43 and day 403).
    6. 21 days after second vaccination (day 43).
    7. 21 days after second and third vaccinations (day 43 and day 403).
    8. 21 days after second and third vaccinations (day 43 and day 403).
    E.5.2Secondary end point(s)
    1. Number of Subjects Reporting Local and Systemic Reactions by Vaccination.
    2. Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the Fluad-H5N1 Influenza Vaccine Mixed extemporaneously With the Seasonal Agrippal.
    3. Geometric Mean Ratio After the Booster Vaccination Against the Fluad-H5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal Agrippal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 21 days after second and third vaccinations (day 43 and day 403).
    2. 21 days after booster vaccination (day 403).
    3. 21 days after booster vaccination (day 403).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Agrippal
    E.8.2.4Number of treatment arms in the trial8
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Colombia
    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.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 405
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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)
    None
    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: Colombia
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