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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41450   clinical trials with a EudraCT protocol, of which   6809   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2017-000089-31
    Sponsor's Protocol Code Number:PREPARE
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000089-31
    A.3Full title of the trial
    Single dose rabies PRE-exposure Priming induces a rapid and effective anamnestic Antibody REsponse
    Inprenting van het immuungeheugen met een enkele dosis rabies vaccin zorgt voor een snelle en effectieve antistof productie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    How well does the immune system remember a single shot with rabies vaccine
    Hoe goed is het immuungeheugen na inprenting met een enkele dosis rabies vaccin
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberPREPARE
    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 SponsorLeiden University Medical Center
    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 supportNetherlands Organisation for Health Research and Development
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointDepartment Infectious Diseases
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.4Telephone number00310715262613
    B.5.5Fax number00310715266758
    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. name rabipur
    D. of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameRabipur
    D.3.2Product code RVG 29095
    D.3.4Pharmaceutical form Lyophilisate and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Intramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRabipur
    D.3.9.2Current sponsor codeRVG 29095
    D.3.9.3Other descriptive nameRABIES VIRUS (INACTIVATED) STRAIN FLURY LEP
    D.3.9.4EV Substance CodeSUB25746
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    healthy volunteer
    gezonde vrijwilliger
    E.1.1.1Medical condition in easily understood language
    rabies vaccination
    inenting tegen hondsdolheid
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10069589
    E.1.2Term Rabies immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the presence of rapid and adequate anamnestic antibody response against rabies virus at six months after primary vaccination with a single intramuscular dose (1.0 mL) or one-fifth fractional intradermal dose of rabies vaccine. The rate of increase in geometric mean concentrations of RVNA observed at day 7, after a standard 2-dose PEP vaccination schedule should be non-inferior to that of the reference group with 2-dose PrEP.
    Aantonen dat het immunologisch geheugen na primo-rabies vaccinatie via intramusculaire weg met een enkelvoudige standaard dosis (1.0 mL) of via intradermale weg met een een-vijfde fractionele dosis (2 x 0.1 mL) even goed kan worden aangesproken (non-inferieur) als na standaard primo-vaccinatie met 2 i.m. dosis
    E.2.2Secondary objectives of the trial
    To determine health beliefs, knowledge and risk perception on animal bites and rabies, and attitude towards vaccination in these travellers before and after travel
    Vaststellen van kennis, risico perceptie en eigen ideeën over bijverwondingen en rabies en de houding van reizigers tegenover rabiesvaccinatie voor en na de reis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Travellers visiting the travel clinics of AMC, Harbour Hospital and LUMC will be invited to participate in this study. In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    Age ≥18 years
    Expected time of departure >1 weeks
    Travelling for less than 8 weeks
    Good health according to investigator
    Willingness and ability to adhere to the study regimen
    Able to provide informed consent
    E.4Principal exclusion criteria
    History of previous rabies vaccination
    Suspected previous vaccination against rabies
    Requirement for standard rabies PrEP according to the national guidelines
    Known or suspected previous vaccination against rabies
    Known or suspected severe allergy against egg protein
    Known or suspected allergy against any of the other vaccine components
    History of unusual or severe reactions to any previous vaccination
    History of (pre)syncope associated with medical procedures involving needles
    Immunocompromized state due to illness or medication
    Administration of plasma or blood products three months prior to inclusion
    (hydroxy)chloroquine or mefloquine use
    History of any neurological disorder including epilepsy
    Pregnancy or breastfeeding
    Any current infectious disease other than seasonal cold
    Bleeding disorders or use of anticoagulants
    Temporary exclusion criterion for vaccination: body temperature ≥ 38.5°C or acute illness will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of increase of GMC of RVNA between day 0 and day 7 after simulated PEP
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 0 and day 7
    E.5.2Secondary end point(s)
    Percentage of travellers with RVNA titer >0.5 IU/mL at day 0, six months after primary vaccination Percentage of travellers with RVNA titer>0.5 IU/mL at day 3, after the simulated post-exposure vaccination

    GMC of RVNA at 0, day 56-63, and 6 months after a single intramuscular dose of rabies vaccine
    GMC of RVNA at 0, day 56-63, and 6 months after a two-site intradermal one-fifth fractional doses of rabies vaccine
    GMC of RVNA at 0, day 63-70 and 6 months after standard PrEP with 2 intramuscular doses of rabies vaccine
    GMC of RVNA at day 0, day 3, day 7 and day 21 after the simulated post-exposure vaccination

    Knowledge, belief and risk perception about animal bites and rabies vaccination, before and after travel
    Percentage of travellers with animal contact during stay abroad

    Type of animal and type of contact (licking, scratching or biting)

    Measures taken after animal contact during travel
    Percentage of travellers who applied wound care after animal contact
    Percentage of travellers who started appropriate PEP after animal contact
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, Day 3, Day 7, Day 56-63/63-70, month 6, month 6 + 3 days, month 6 + 7 days, months 6 + 21 days
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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. 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 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 Yes
    E. trial design description
    laboratory (RVNA) blinded from allocation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    standard vaccination schedule
    E.8.2.4Number of treatment arms in the trial4
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 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: 264
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 104
    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 state368
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-09
    P. End of Trial
    P.End of Trial StatusOngoing
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