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    Summary
    EudraCT Number:2010-018350-13
    Sponsor's Protocol Code Number:S201.3.130
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-04
    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
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-018350-13
    A.3Full title of the trial
    Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2010/2011. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects ≥18 and ≤60 Years and Elderly Subjects ≥ 61 Years of Age.
    A.3.2Name or abbreviated title of the trial where available
    Influvac Annual Update 2010/2011
    A.4.1Sponsor's protocol code numberS201.3.130
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Influvac® 2010/2011
    D.2.1.1.2Name of the Marketing Authorisation holderSolvay Biologicals B.V.. Submit variation in April - MA holder will be Abbott Biologicals B.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 2010/2011
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeS201.3.130
    D.3.9.3Other descriptive nameA/California/7/2009 (H1N1)-like; A/Perth/16/2009 (H3N2)-like strain; B/Brisbane/60/2008-like strain
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15 μg per strain
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective: To determine the immunogenicity of the trivalent influenza subunit
    vaccine Influvac® for the season 2010/2011, in two groups:
    - Adult subjects aged ≥18 and ≤ 60 years.
    - Elderly subjects ≥ 61 years of age.

    Safety Objective: To collect data on the safety and tolerability (reactogenicity and overall inconvenience) of Influvac®.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.

    2. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.

    3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on medication for a condition, the medication dose must have been stable for at least three months preceding study vaccination).
    E.4Principal exclusion criteria
    1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.

    2. A serious adverse reaction after a previous (influenza) vaccination.

    3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.

    4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.

    5. A history of Guillain-Barré syndrome or active neurological disease.

    6. Having fever and/or presenting with an acute disease or infection on the day of study vaccination.

    7. Having any condition affecting the immune system e.g., autoimmune disease.

    8. Receipt of vaccines (live or inactivated) within four weeks before study vaccination or planned vaccination (other than with the study vaccine) during the study period.

    9. Using or having used medication that influences the immune system (such as corticosteroids) during the four weeks prior to the study 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.

    10. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination.

    11. Receipt of another investigational agent within 30 days prior to study vaccination, or planned use during the study period.

    12. Known drug or alcohol abuse

    13. Planned surgery during the study period.

    14. Being pregnant (positive urine pregnancy test at the day of study vaccination), breastfeeding or a desire to become pregnant during the study.

    15. Not using a medically accepted method of birth control including abstinence during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    Anti-HA antibody response is an established correlate of protection against influenza. Therefore, the primary efficacy variable will be HI titers and its derived parameters as defined by the CHMP guideline for influenza vaccines.

    The following serological parameters will be derived from the individual HI antibody titers, separately for each strain:
    - the pre-and post-vaccination seroprotection rates, with seroprotection defined as an HI titer ≥ 40
    - the seroconversion rate, with seroconversion defined as a pre-vaccination HI titer < 10 and a post-vaccination HI titer ≥40
    - the proportion of subjects with at least a 4-fold increase in HI titer, i.e., the proportion of subjects with a pre-vaccination HI titer ≥10 and a post-vaccination relative increase of ≥ 4-fold
    - the proportion of subjects with seroconversion or at least a 4-fold increase in HI titer
    - the mean fold increase, which is the geometric mean of the intra-individual increases (i.e., post-vaccination HI titer/pre-vaccination HI titer).


    The results of the serological analysis will be evaluated according to the CHMP Note for Guidance which requires that for both age groups at least one of the following criteria is met for each of the three strains:

    Criterion adults elderly

    Seroprotection rate: > 70% > 60%
    Seroconversion/4-fold increase rate: > 40% > 30%
    Mean fold increase: > 2.5 > 2.0
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2010-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
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