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    The EU Clinical Trials Register currently displays   35918   clinical trials with a EudraCT protocol, of which   5893   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
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    Summary
    EudraCT Number:2009-015743-16
    Sponsor's Protocol Code Number:NA
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-015743-16
    A.3Full title of the trial
    A randomised, partially observer-blind, multi-centre, head-to-head comparison of a two dose regimen of Baxter and GSK H1N1 pandemic vaccines, administered 21 days apart
    A.3.2Name or abbreviated title of the trial where available
    Head to head study of influenza H1N1 vaccines in adults
    A.4.1Sponsor's protocol code numberNA
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN92328241
    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 SponsorUniversity Hospitals of Leicester NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 nameCelvapan
    D.3.2Product code Celvapan
    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.3.11 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.IMP: 2
    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 Pandemrix
    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.3.11 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
    Pandemic H1N1 influenza.
    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 immunogenicity of Baxter cell-culture, non-adjuvanted, whole virus H1N1 vaccine, and GSK AS03-adjuvanted, split H1N1 vaccine with respect to Committee of Human Medicinal Products (CHMP) and FDA licensing criteria.
    E.2.2Secondary objectives of the trial
    To identify whether one or two doses of vaccine are required to satisfy the licensing criteria,
    To examine the short term reactogenicity of the vaccines,
    To examine the kinetics of the antibody responses to vaccination,
    To examine persistence of antibody at 6 months,
    AND if appropriate (i.e., an antigenic drift variant emerges prior to the 2010-2011 influenza season),
    To evaluate the breadth of the antibody response to the antigenic variant.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
    Clinically healthy, male or female volunteers aged 18 years of age and older, including the over 65’s, and those with stable high-risk medical conditions. (NOTE: ‘Stable’ is defined as having no medical consultations for an exacerbation or worsening of any chronic medical condition during the preceding 8 weeks, AND have been maintained on a stable drug regimen for at least 2 weeks prior to study entry as assessed by the medical history).
    Are able to understand and comply with all study procedures and to complete study diaries,
    Individuals who can be contacted and are available for all study visits.
    Females should either be using secure contraceptive precautions including a) the oral contraceptive pill, b) condom/barrier contraception c) partner has had a vasectomy, d) be surgically sterilised, or e) post-menopausal (defined as at least two years since the last menstrual period).
    E.4Principal exclusion criteria
    1 Subjects who are unable to lead an independent life either physically or mentally;
    2 Women should not be pregnant or lactating;
    3 Women who refuse to use a reliable contraceptive method Days 0 to 42 of the study;
    4 Confirmed H1N1 infection, as determined by laboratory tests;
    5 Have received Oseltamivir or Zanamivir for influenza-like illness since May 2009;
    6 Have a household member who had confirmed H1N1 infection, as determined by laboratory tests, and/or received Oseltamivir or Zanamivir for influenza-like illness since May 2009;
    7 Receipt of another investigational agent (vaccine or medicinal product) in the preceding 4 weeks;
    8 Unwilling to refuse participation in another study during Days 0 to 42 of the study;
    9 Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder;
    10 Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable);
    11 Subjects who had a temperature >38oC within 3 days of vaccination;
    12 Any acute illness at the time of vaccination. Note: minor infections without fever or systemic upset are not contraindications/exclusion criteria;
    13 Subjects with known or suspected impairment/alteration of immune function, including:
    • receipt of oral immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process (Note: long-term, inhaled steroids for asthma management is acceptable),
    • receipt of immunostimulants or interferon,
    • receipt of an immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months of the study;
    • Anyone at high risk of developing immunocompromising condition;
    • Received radiotherapy or chemotherapy during the 6 months preceding the study;
    14 Subjects for whom surgery is planned during Days 0 to 42 of the study;
    15 Regularly drink more than 40 units of alcohol weekly;
    16 Known or suspected drug abuse (recreational or prescribed);
    17 Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results;
    18 Subjects with a history of anaphylaxis or serious reactions to vaccines; known hypersensitivity (other than anaphylactic reaction) to influenza viral protein, to any component of the study vaccines, to products containing mercury and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate, sodium deoxycholate, and benzonase).
    19 Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine;
    20 Actual or planned receipt of another vaccine, including seasonal influenza vaccine, during the period 3 weeks before to 3 weeks after vaccination on Days 0 and 21.
    E.5 End points
    E.5.1Primary end point(s)
    MEASURES OF IMMUNOGENICITY
    Immunogenicity will be measured by haemagglutination inhibition (HI), neutralizing antibody (MN) and possibly single radial haemolysis (SRH) antibody responses to influenza H1N1 at each visit.

    The principal objective of the study is to evaluate the immunogenicity of each dose of Baxter cell-culture, non-adjuvanted, whole virus H1N1 vaccine, and GSK AS03-adjuvanted, split H1N1 vaccine with respect to Committee of Human Medicinal Products (CHMP) and FDA licensing criteria, i.e., 21 days after the first and second doses.

    Immunogenicity will be assessed in terms of the ‘magnitude’ and ‘kinetics’ of the antibody response, and, when appropriate, the ‘breadth’ of the antibody response:

    • MAGNITUDE: i.e., measurement of the antibody titres (to the vaccine strain) to one and two 0.5mL intramuscular (IM) doses of Baxter and GSK vaccines (i.e., by comparing (i) mean geometric increases [ratio of day 21 GMT/day 0 GMT and ratio of day 42 GMT/day 0 GMT, by age group and all age groups combined ]; (ii) the seroconversion rate, or significant increases in titre; and (iii) the seroprotection rate;
    • KINETICS: i.e., application of the above immunogenicity criteria 7 and 14 days after each dose, after each vaccine type, in each age group, and in all age groups combined;
    and
    • BREADTH: i.e., application of the above immunogenicity criteria 21 days after each dose, after each vaccine type, in each age group, and in all age groups combined, to any antigenic drift variant that emerges prior to the 2010-2011 influenza season.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned3
    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 subject last visit for completion of the clinical phase of the study, BUT the study will be completed when the laboratory analyses are done.
    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 months7
    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 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 Yes
    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 state360
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    This is NOT a treatment study, it is a vaccine immnogenicity study. We are not altering treatment or care of anyone who is receiving any medication.
    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 Decision2009-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-01
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