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    Summary
    EudraCT Number:2018-004707-40
    Sponsor's Protocol Code Number:RAB40
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-02-25
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2018-004707-40
    A.3Full title of the trial
    Verorab® immunogenicity and safety after a one week, 4-site, intradermal (ID) post-exposure prophylaxis regimen (4-4-4-0-0) followed by a one visit, 4-site, ID booster at five years.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Verorab® immunogenicity and safety after a one week, 4-site, intradermal (ID) post-exposure prophylaxis regimen (4-4-4-0-0) followed by a one visit,
    4-site, ID booster at five years.
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen
    A.4.1Sponsor's protocol code numberRAB40
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01622062
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1117-7193
    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 SponsorSanofi Pasteur SA
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur
    B.5.2Functional name of contact pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryFrance
    B.5.6E-mailContact-US@sanofi.com
    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 Verorab®: Purified Vero cell Rabies Vaccine (PVRV)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWistar rabies PM/WI 38 1503-3M strain
    D.3.9.3Other descriptive nameRABIES VIRUS (INACTIVATED) STRAIN WISTAR (PM/WI 38-1503-3M)
    D.3.9.4EV Substance CodeSUB25743
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 FAVIRAB®, purified Equine Rabies Immunoglobulin (pERIG)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpurified Equine Rabies Immunoglobulin (pERIG)
    D.3.9.3Other descriptive nameF(AB’)2 FRAGMENTS OF EQUINE ANTIRABIES IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB25603
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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
    Rabies
    E.1.1.1Medical condition in easily understood language
    Rabies
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen.
    E.2.2Secondary objectives of the trial
    •Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90.
    •Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group.
    •Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5.
    •Safety: To describe the safety profile of each group after the primary and booster vaccinations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all patients:
    •Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site.

    For adults:
    •Informed consent form has been signed and dated.
    •Able to attend all scheduled visits and to comply with all trial procedures.

    For children:
    •For children under 18 years of age, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative.
    •For children under 18 years, assent form or informed consent form has been signed and dated by the appropriate age-range patient, according to country specific institution requirement as detailed in each country specific assent form or informed consent form.
    •Patient and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
    E.4Principal exclusion criteria
    For all patients:
    •Receipt of chloroquine or other medications used for malaria chemoprophylaxis, with or without other anti-malarial treatment, for more than 4 weeks (duration of anti-malarial course) and part of the treatment received within the 2 weeks before vaccination.
    •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial immunization
    •Planned participation in another clinical trial during the present trial period
    •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination and tetanus immunization (related only to current animal bite exposure
    •Planned receipt of any vaccine in the 4 weeks following the trial primary and booster vaccination
    •Previous immunization against rabies at any time in the past with either the trial vaccine and immunoglobulin or another rabies immunobiological product (in pre-or post-exposure regimen)
    •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
    •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
    •Self-reported seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
    •Patient with clinical signs of encephalitis
    •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
    •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    •Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
    •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    •Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
    •Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
    •Prior history of mammal animal bite within the past 5 years.

    For infants or toddlers :
    •Known personal or maternal seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus, as reported by the parent/guardian
    •Prior history of seizures
    E.5 End points
    E.5.1Primary end point(s)
    1.Percentage of participants with seroconversion on Day 14
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
    E.5.1.1Timepoint(s) of evaluation of this end point
    [ Time Frame: Day 14 post vaccination ]
    E.5.2Secondary end point(s)
    1.Percentage of participants with seroconversion before and after primary vaccination
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL


    2.Percentage of participants with seroconversion after primary vaccination (antibody persistence)
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL


    3.Percentage of participants with seroconversion after booster vaccination
    Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL


    4.Geometric mean titers (GMTs) before and after primary vaccination
    Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test


    5.GMTs after primary vaccination (antibody persistence)
    Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test


    6.GMTs after booster vaccination
    Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test


    7.Number of participants reporting solicited injection site reactions following primary and booster vaccination
    Solicited injection site reactions are tenderness (for participants aged ≤ 23 months), pain (for participants aged ≥ 2 years), redness and swelling (for all participants)


    8.Number of participants reporting solicited systemic reactions following primary and booster vaccination
    Solicited systemic reactions are Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability for participants aged ≤ 23 months and Fever (Temperature), Headache, Malaise, and Myalgia for participants aged ≥ 2 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.[ Time Frame: Day 0, Day 14, Day 90 ]


    2.[ Time Frame: Year 1 to Year 5 ]


    3.[ Time Frame: Year 5 + 11 days ]


    4.[ Time Frame: Day 0, Day 14, Day 90 ]



    5.[ Time Frame: Year 1 to Year 5 ]



    6.[ Time Frame: Year 5 + 11 days ]


    7.[ Time Frame: 7 days after each and any injection ]


    8.[ Time Frame: From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections ]
    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 Yes
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Philippines
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days2
    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: 250
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    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 No
    F.3.2Patients Yes
    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
    infants, toddlers, children, adolescents (minors)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 600
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Philippines
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