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    Summary
    EudraCT Number:2015-003325-33
    Sponsor's Protocol Code Number:UAM1
    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:2015-08-25
    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 number2015-003325-33
    A.3Full title of the trial
    A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy OPV-vaccinated adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A vaccine study in healthy adults to evaluate the safety and immune response of a licensed oral polio vaccine containing the polio vaccine 2 strain
    A.4.1Sponsor's protocol code numberUAM1
    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 SponsorUniversity of Antwerp
    B.1.3.4CountryBelgium
    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 supportBill and Melinda Gates Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Antwerp
    B.5.2Functional name of contact pointProf. Dr. PhD.
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitsplein 1, Campus Drie Eiken
    B.5.3.2Town/ cityAntwerp
    B.5.3.3Post code2610
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)3265 26 58
    B.5.5Fax number+32(0)3265 26 40
    B.5.6E-mailphilippe.beutels@uantwerpen.be
    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 Polio Sabin™ Mono Two
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 nameSABIN monovalent Oral Polio Vaccine type 2
    D.3.2Product code mOPV2
    D.3.4Pharmaceutical form Oral drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitis vaccine type 2 (live, attenuated)
    D.3.9.2Current sponsor codeSABIN mOPV2
    D.3.9.3Other descriptive namePOLIOVIRUS (LIVE, ATTENUATED) TYPE 2 (SABIN STRAIN)
    D.3.9.4EV Substance CodeSUB27075
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50/dose cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10^5
    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) 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
    Polio disease
    E.1.1.1Medical condition in easily understood language
    Polio disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10036017
    E.1.2Term Poliomyelitis viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are to assess the safety (serious adverse events [SAEs] and severe adverse events [AEs]) and immunogenicity (seroprotection rate) of SABIN mOPV2 in healthy OPV-vaccinated adults.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess:
    -the safety (solicited and unsolicited AEs, important medical events [IMEs], laboratory assessments) of SABIN mOPV2 in healthy OPV-vaccinated adults
    -the immunogenicity (seroconversion rate, median antibody titer) of SABIN mOPV2 in healthy OPV-vaccinated adults.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male or female, between 18 and 50 years old, extremes included
    2. Received at least 4 doses of OPV in the past (more than 12 months before the start of the study)
    3. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0
    4. Female subjects of childbearing potential must agree to the use of an effective method of birth control throughout the study and up to 3 months after last vaccine dose
    5. Willing to adhere to the prohibitions and restrictions specified in the protocol
    6. Informed Consent Form (ICF) signed voluntarily by the subject before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
    E.4Principal exclusion criteria
    1. A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements
    2. Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
    3. A known allergy, hypersensitivity, or intolerance to the study vaccine, or to any of its components, or to any antibiotics
    4. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus [HIV] infection)
    5. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete priming) within 28 days after vaccination
    6. Neonatal nurses or others having professional contact with children under 6 months old within 28 days after vaccination
    7. Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day (inhaled and topical steroids are allowed, whereas intra-articular and epidural injection/administration of steroids are not allowed)
    8. Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting
    9. Indications of drug abuse or excessive use of alcohol at Day 0
    10. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at Day 0. Subjects with a positive pregnancy test will be excluded
    11. Participation in another clinical study within 28 days prior to entry in this study or receipt of any investigational product (drug or vaccine) other than the study vaccine within 28 days prior to the first administration of study vaccine, or planned use during the study period
    12. Planned administration or administration of any vaccine other than the study vaccine within 28 days of the first dose of study vaccine and up to 28 days after administration of each study vaccine dose.
    13. Administration of polio vaccine within 12 months before the start of the study.
    14. Having had a transfusion of any blood product or application of immunoglobulins within the 4 weeks prior to the first administration of study drugs or during the study.
    15. Subject is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or is a family member of an employee or the Investigator.

    E.5 End points
    E.5.1Primary end point(s)
    - Safety: incidence of SAEs and severe§ AEs considered related or possibly related to study vaccine throughout the study period.
    - Immunogenicity: seroprotection rate of type 2 polio antibodies at Day 28. Seroprotection is defined as type 2-specific antibody titers ≥1:8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Safety: throughout study period
    - Immunogenicity: at Day 28
    E.5.2Secondary end point(s)
    Safety:
    1) The incidence of any SAEs and IMEs throughout the study period. The following will be considered IMEs: medically significant events that do not meet any of the SAE criteria, but may require medical or surgical consultation or intervention to prevent one of the other serious outcomes listed in the SAE definition.
    2) The incidence and severity of solicited AEs for Days 0-7 in both groups and days 28-35 in Group 2
    3) The incidence and severity of unsolicited AEs throughout the study period
    4) Incidence and description of deviations from normal of safety chemistry at Day 0 (both groups), Day 7 (both groups), Day 28 (both groups), Day 35 (Group 2), and Day 56 (Group 2).

    Immunogenicity:
    5) Median antibody titers of type 2 polio antibodies at Day 28 in Group 1
    6) Seroprotection rate and median antibody titers of type 2 polio antibodies at Day 56 in Group 2
    7) Seroconversion rate of type 2 polio antibodies at Day 28 in both groups and at Day 56 in Group 2. Seroconversion is defined as a change from seronegative to seropositive and antibody titers of ≥1:8, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline titers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:
    1) Throughout the study period
    2) Day 0-7 (both groups) and Day 28-35 (Group 2)
    3) Throughout the study period
    4) Day 0 (both groups), Day 7 (both groups), Day 28 (both groups), Day 35 (Group 2), and Day 56 (Group 2)

    Immunogenicity:
    5) Day 28 (Group 1)
    6) Day 56 (Group 2)
    7) Day 28 (both groups) & Day 56 (Group2)
    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 (seroprotection rate)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 No
    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
    A subject will be considered to have completed the study if he or she has completed all study related procedures 42 days after the last study vaccination.
    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 months7
    E.8.9.1In the Member State concerned days16
    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: 100
    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 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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
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