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    Summary
    EudraCT Number:2015-003544-39
    Sponsor's Protocol Code Number:M3-ABMG
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-18
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2015-003544-39
    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 IPV-vaccinated children aged 1 to 5 years in Lithuania
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clincal study to evaluate the safety of a polio vaccine type 2 given orally in healthy children aged 1 to 5 years previously treated with inactivated polio vaccine in Lithuania
    A.4.1Sponsor's protocol code numberM3-ABMG
    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 SponsorFIDEC - Fighting Infectious Diseases in Emerging Countries
    B.1.3.4CountryUnited States
    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 organisationVilnius University, Santariskiu Clinic
    B.5.2Functional name of contact pointClinic of Children Diseases
    B.5.3 Address:
    B.5.3.1Street AddressSantariskiu 4
    B.5.3.2Town/ cityVilnius
    B.5.3.3Post codeLT-08406
    B.5.3.4CountryLithuania
    B.5.4Telephone number+37052492414
    B.5.5Fax number+37052720368
    B.5.6E-mailvytautas.usonis@mf.vu.lt
    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 TM Mono Two (oral) Monovalent Oral Poliomyelitis vaccine Type 2 (mOPV2)
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    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 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 INNPolio Sabin Mono Two
    D.3.9.2Current sponsor codeSABIN mOPV2
    D.3.9.3Other descriptive namePOLIOVIRUS (LIVE, ATTENUATED) TYPE 2 (SABIN STRAIN P712, Ch, 2ab
    D.3.9.4EV Substance CodeSUB27075
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5.0
    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
    evaluation of safety of SABIN mOPV2 in healthy IPV-vaccinated children of 1 – 5 years of age (Polio disease)
    E.1.1.1Medical condition in easily understood language
    evaluation of safety of specific oral polio vaccine type 2 in children aged 1 to 5 previously treated with inactivated polio vaccine (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 LLT
    E.1.2Classification code 10036016
    E.1.2Term Poliomyelitis NOS
    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] grade 3 according to CTCAE 4.03) and immunogenicity (seroprotection rate) of one dose of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess:
    - The safety (mild and moderate solicited and unsolicited AEs, Important Medical Events [IMEs], and laboratory assessments) of one or two doses SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years
    - The safety (serious adverse events [SAEs] and severe adverse events [grade 3 AEs according to CTCAE 4.03]) of two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years
    - The immunogenicity (seroprotection rate) of two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years
    - The immunogenicity (seroconversion rate, median and geometric mean antibody titers) of one or two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years
    - The baseline seroprotection rates against all 3 polio types at Day 0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 1 to 5 years of age, previously vaccinated with three or four doses of IPV.
    2. Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
    3. Written informed consent obtained from 2 parents or legal guardian(s) as per country regulations
    E.4Principal exclusion criteria
    1. Previous vaccination against poliovirus outside the national immunization schedule.
    2. Polio vaccines including polio combined vaccines within the 3 months prior to the administration of the study vaccine (number of previous polio vaccine doses to be documented).
    3. Any vaccine in the previous 4 weeks.
    4. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
    5. Family history of congenital or hereditary immunodeficiency.
    6. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
    7. Known allergy to any component of the study vaccines or to any antibiotics.
    8. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    9. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
    10. Member of the subject’s household (living in the same house or apartment unit) has received OPV in the last 3 months.
    11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
    E.5 End points
    E.5.1Primary end point(s)
    The following endpoints will be evaluated by group and overall:
    - Safety: incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in both groups.
    - Immunogenicity: seroprotection rate of type 2 polio neutralizing antibodies at Day 28 following the first dose of SABIN mOPV2 in both groups.
    (Seroprotection is defined as type 2-specific antibody titers ≥1:8 and seroprotection rate as the percentage of seroprotected subjects per group.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Safety: will be evaluated throughout the study period
    - Immunogenicity: will be evaluated at day 28 following the first dose of mOPV2
    E.5.2Secondary end point(s)
    The following safety and immunogenicity endpoints will be evaluated by group and overall.
    Safety:
    - Incidence of any SAEs, any AEs grade 3, and any 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.)
    - Incidence of any mild and moderate solicited AEs for 7 days after the first dose in both groups and for 7 days after the second dose in Group 2;
    - Incidence of any mild and moderate unsolicited AEs throughout the study period;
    - Incidence and description of deviations from normal of safety chemistry at Day 0 (both groups), 7 and 28 days after the first dose in Groups 1 and 2 and at 7 and 28 days after the second dose in Group 2.
    Immunogenicity:
    - Seroprotection rate at day 28 after the second dose of SABIN mOPV2 in Group 2.
    - The baseline seroprotection rates against all 3 polio types at Day 0
    - Median and geometric mean antibody titers of type 2 polio neutralizing antibody titers at day 0, day 28 after dose 1, and day 28 after dose 2 (group 2).
    - Seroconversion rate of type 2 polio neutralizing antibodies at 28 days after the first dose in Groups 1 and 2 and at 28 days after the second dose in Group 2.
    (Seroconversion is defined as a change from seronegative to seropositive and antibody titers of ≥1:8, and in seropositive subjects, an antibody titer increase of ≥4 fold over baseline titers).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Incidence of any SAEs, any AEs grade 3, any IMEs, mild and moderate unsolicited AEs throughout the study period.
    - Incidence of any mild and moderate solicited AEs for 7 days after the first dose in both groups and for 7 days after the second dose in Group 2
    - deviations from normal of safety chemistry at Day 0 (both groups), 7 and 28 days after the first dose in Groups 1 and 2 and at 7 and 28 days after the second dose in Group 2

    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 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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    The study completion date is considered to be the date on which the final serologic analysis is performed to obtain data for the purpose of assessing the primary immunogenicity objective, i.e. the proportions of each group with seroprotective type 2 polio neutralizing antibodies at Day 28 following the first dose of mOPV2.
    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
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children from 1 to 5 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    standard of care
    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 Decision2015-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-12
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