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    Summary
    EudraCT Number:2009-015700-26
    Sponsor's Protocol Code Number:AH1N1-483-09THL
    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:2009-09-29
    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 number2009-015700-26
    A.3Full title of the trial
    Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study.

    A(H1N1)v-pandemiarokotuskampanjan vaikutukset
    A.3.2Name or abbreviated title of the trial where available
    Pandemiarokotuskampanjatutkimus
    A.4.1Sponsor's protocol code numberAH1N1-483-09THL
    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 SponsorNational Institute for Health and Welfare
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 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 namePandemrix
    D.3.2Product code A(H1N1)v influenza vaccine
    D.3.4Pharmaceutical form Concentrate and solvent for solution 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.3.9.2Current sponsor codeA(H1N1)v influenza vaccine
    D.3.9.3Other descriptive namehaemagglutinin/A/California/7/2009 (H1N1)v-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    Influenza caused by the new A(H1N1)v influenza virus ("swine influenza")
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10022001
    E.1.2Term Influenza (epidemic)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effectiveness of an A(H1N1)v influenza vaccination in preventing the first episode of laboratory-confirmed infection with the novel, pandemic influenza A(H1N1)v virus among community-dwelling and recently vaccinated adults as compared to unvaccinated adults from a cohort of at least 4,000 persons
    E.2.2Secondary objectives of the trial
    • To assess the safety for 6 months after vaccination with the A(H1N1)v vaccine during the follow up;
    • To determine humoral and cellular immune responses to one or two doses of the A(H1N1)v vaccine in 200 adults aged 18 to 75 years
    • To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the novel A(H1N1)v influenza virus;
    • To explore the effectiveness of the A(H1N1)v vaccine in subgroups stratified by age
    • To study the narcolepsy associated risk and protective HLA genotypes in the subgroup of the individuals in whom the immune responses to A(H1N1)v vaccine are studied (immunogenicity cohort) and to evaluate the effect of these genotypes on the characteristics of immune responses to to A(H1N1)v vaccine
    • To explore the systemic inflammatory responses induced by A(H1N1)v vaccine in the follow-up serum samples from the individuals of the immunogenicity cohort

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy 1. A(H1N1)v-immunogeenisuustutkimus : included in the main protocol V1.0, 27.8.2009; the immunogenicity cohort. Objective: to determine humoral and cellular immune responses to one or two doses of the A(H1N1)v vaccine in 200 adults aged 18 to 75 years.

    Substudy 2. A(H1N1)v-rokote ja tulehdusreaktio : included in the Amendment 1, version 2, 23.9.2010 of the main protocol. Objectives: 1) To study the narcolepsy associated risk and protective HLA genotypes in the subgroup of the individuals in whom the immune responses to A(H1N1)v vaccine are studied (immunogenicity cohort) and to evaluate the effect of these genotypes on the characteristics of immune responses to to A(H1N1)v vaccine. 2) To explore the systemic inflammatory responses induced by A(H1N1)v vaccine in the follow-up serum samples from the individuals of the immunogenicity cohort
    E.3Principal inclusion criteria
    • Full legal competence;
    • Written informed consent obtained;
    • Assigned to use the services of Tampere health centre and community-dwelling;
    • At least 18 and no more than 75 years old, inclusive;
    • Belongs to the target group of A(H1N1)v vaccination in the region during the pandemic vaccination campaign;
    • Able to communicate fluently in Finnish or Swedish
    • Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate.
    E.4Principal exclusion criteria
    • For the total study cohort, no specific exclusion criteria will be applied;
    • For the subgroup for follow-up of immunogenicity of the vaccine (immunogenicity cohort), exclusion criteria comprise:
    o previous severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine
    o previous severe allergic reaction to eggs
    o significant immunological disorder
    E.5 End points
    E.5.1Primary end point(s)
    Effectiveness: occurrence of laboratory-confirmed infection with the novel, pandemic influenza A(H1N1)v virus in vaccinated and not vaccinated persons

    Case definition: A(H1N1)v influenza virus identified by reverse transcription polymerase chain reaction from a combined nasal and throat swab specimen obtained within five days after onset of following self-reported clinical signs and symptoms: fever (>= 38 °C) and at least one sign or symptom of acute respiratory infection, or pneumonia diagnosed by a physician.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) 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.8.3 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 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
    Last visit of the last subject (LVLS) 30.4.2010 at latest (for the substudy 'A(H1N1)v-immunogeenisuustutkimus' LVLS 7 months after the last vaccination at latest), register data follow up at least 6 months after LVLS and for infants born to pregnant women until the child is one year old. If a a special reason rises during the epidemic, the register data follow up will last up to 3 years after the start of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=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 Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state4000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4000
    F.4.2.2In the whole clinical trial 4000
    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)
    Normal treatment
    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 Decision2009-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-30
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