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    The EU Clinical Trials Register currently displays   36821   clinical trials with a EudraCT protocol, of which   6079   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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    EudraCT Number:2005-002175-32
    Sponsor's Protocol Code Number:VVL04
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2005-002175-32
    A.3Full title of the trial
    Take evaluation and safety of smallpox vaccine (LISTER strain) in naïve healthy adults
    A.4.1Sponsor's protocol code numberVVL04
    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 SponsorSanofi Pasteur SA
    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.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 Information not present in EudraCT
    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 nameSmallpox vaccine, LISTER strain, produced on chick embryo cells (VV LISTER/CEP)
    D.3.2Product code 339
    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 IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameLive vaccinia virus (LISTER strain)
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10exp8
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Vaccination of vaccinia-naive healthy adults (18-25 years old)
    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 estimate the smallpox vaccination take rate in naïve healthy adults.
    E.2.2Secondary objectives of the trial
    1) To describe local signs and symptoms of the take.
    2) To describe the safety of the vaccine in naïve healthy adults
    3) To describe the antibody response to vaccination on D0 and D28
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients aged 18 to 25 years on the day of screening
    2. Informed consent form signed
    3. Able to attend all scheduled visits and to comply with all trial procedures
    4. For a woman, inability to bear a child or negative serum pregnancy test performed at screening (checked at V01)
    5. Subject entitled to national social security
    6. Subject registered in the French file of healthy volunteers in clinical trials
    7. For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least three months prior to screening to three months following trial vaccination
    8. For a woman, inability to bear a child or negative urine pregnancy test
    E.4Principal exclusion criteria
    Exclusion criteria 1 to 27 will be checked at screening and on D0:
    1. Previous smallpox vaccination confirmed by vaccination record or typical scar
    2. Participation in another clinical trial in the three months preceding the trial vaccination
    3. Planned participation in another clinical trial during the present trial period
    4. Chronic illness at a stage that could interfere with trial conduct or completion
    5. Breast-feeding
    6. Allergy to any known components of vaccinia immune globulin or previous allergic reaction to immunoglobulins
    7. Systemic hypersensitivity to eggs or to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine
    8. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or any treatment including corticosteroids (systemic, topical, ophthalmic)
    9. Treatment with antiviral drugs (interferon, vidarabine, acyclovir, etc.) within one month before vaccination
    10. History of organ or bone marrow transplant
    11. History of skin disorders or atopy (such as progressive eczema, eczema, atopic dermatitis, Darier’s disease, severe acnea, etc.)
    12. History of autoimmune disease (multiple sclerosis, lupus, etc.) in the subject’s parents, siblings or children
    13. History or current cardiac disease: ECG abnormalities, pericarditis, myopericarditis, myocardial infarction/heart attack, angina pectoris, congestive heart failure, cardiomyopathy, arrhythmia, stroke or transient ischemic attacks, or chest pain or shortness of breath with activity (such as walking up stairs), or other coronary artery disease and heart conditions under the care of a physician and associated with a heart condition, or family history of sudden death before the age of 50 years
    14. History or current central nervous system disease: neurodegenerative, infectious, or progressive tumoral disease, or epilepsy
    15. Subject having three or more major risk factors, including: current tobacco use, hypertension, hypercholesterolemia, hypertriglyceridemia, diabetes mellitus, or family history of heart disease (a heart condition before age 50 in a parent, brother, or sister)
    16. Ongoing acute infectious disease
    17. Blood or blood-derived products received in the past six months
    18. Any vaccination with a live-attenuated vaccine within the 60 days preceding the trial vaccination
    19. Any vaccination (other than a live-attenuated vaccine) in the four weeks preceding the trial vaccination
    20. Vaccination planned in the eight weeks following the trial vaccination
    21. Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
    22. Planned or foreseeable close contact after vaccination with infants of less than 12 months of age, or with immunosuppressed persons, pregnant and/or lactating woman, or with persons known to have chronic eczema, or severe skin disorders until the crust separates, leaving a permanent scar at the vaccination site
    23. Planned practice of contact sports or water sports after vaccination until the crust separates, leaving a permanent scar at the vaccination site
    24. Cutaneous lesion near the vaccination site
    25. Apparent lack of personal hygiene
    26. Lack of understanding of the questionnaire
    27. Subject deprived of freedom by an administrative or court order, or in an
    emergency setting, or hospitalized without his/her consent

    The following exclusion criteria will be checked on D0 only:
    28. HIV, hepatitis B (Ag HBs) or hepatitis C seropositivity (screening tests)
    29. Abnormal laboratory values for hematological parameters or cardiac enzymes (screening tests)
    30. Any medical disease / condition (severe skin problems or immune system problems of subject or their close contacts) according to the questionnaire given at the screening visit
    31. Febrile illness (oral temperature ≥ 37.5°C, rectal equivalent temperature ≥38.0°C) on the day of vaccination
    32. Acute intercurrent illness
    33. Absence or unreturned completed questionnaire
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the take for each subject on D9 (Day), D14, D21, and D28. The take is defined as the occurrence of a post-vaccination pock at the vaccination site (a pock is a typical major cutaneous lesion [erythematous papule, vesicle, or pustule]).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) 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.8.5The 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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) 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 Information not present in EudraCT
    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 2005-06-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state260
    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 Decision2005-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
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