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    Summary
    EudraCT Number:2015-000382-31
    Sponsor's Protocol Code Number:205214
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-29
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-000382-31
    A.3Full title of the trial
    A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis with Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately from a Japanese Encephalitis Vaccine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate immune responses to rabies vaccine in adults who received different primary rabies vaccination regimens.
    A.3.2Name or abbreviated title of the trial where available
    RABIES-018 BST:017 (V49_23E1)
    A.4.1Sponsor's protocol code number205214
    A.5.4Other Identifiers
    Name:V49_23E1Number:Other Identifier
    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 SponsorGlaxoSmithKline Biologicals S.A.
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals S.A.
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number+44208990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Rabipur
    D.2.1.1.2Name of the Marketing Authorisation holderBavarian Nordic A/S
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 in pre-filled syringe
    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 INNRabies vaccine
    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 international unit(s)
    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.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 is caused by a virus that can be transfered via a bite from an infected animal. The virus can generate inflammation of the brain, leading to death within 2 weeks if no intensive care is set up.
    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 PT
    E.1.2Classification code 10037742
    E.1.2Term Rabies
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity Objectives:
    1. To compare the long-term (up to approx.10 years) persis-tence of antibody responses (i.e. time until antibody concentra-tions drop below 0.5 IU/mL) in subjects who received a primary series of accelerated or conventional rabies PrEP intramuscular (IM) regimen in the parent study V49_23.
    2. To evaluate the antibody responses to a booster dose of Purified Chick Embryo Cell-Culture (PCEC) rabies vaccine ad-ministered to subjects with Rabies Virus Neutralizing Antibody (RVNA) concentrations < 0.5 IU/mL following a primary
    series of accelerated or conventional rabies PrEP IM regimen in the parent study V49_23.

    Safety Objective:
    To evaluate the safety of a booster dose of PCEC rabies vaccine following a primary series of accelerated or conventional rabies PrEP IM regimen in the parent study V49_23.
    E.2.2Secondary objectives of the trial
    Immunogenicity Objective:
    To evaluate the long-term (up to approx.10 years) immunogen-icity in subjects who received a primary series of accelerated or conventional rabies PrEP intramuscular (IM) regimen in the parent study V49_23.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
    1. All individuals who were randomized to Conventional Rabies and JE vaccination or to Accelerated Rabies and JE vac-cination or to Conventional Rabies groups during the par-ent study, who received the full PrEP regimen and com-pleted the trial following V49_23 study protocol.
    2. Individuals who have voluntarily given written informed con-sent after the nature of the study has been explained ac-cording to local regulatory requirements, prior to study en-try.
    3. Individuals who can comply with study procedures
    4. Males
    Or
    Females of non-childbearing potential
    Or
    Females of childbearing potential who are using an effective birth control method which they intend to use for at least 6 months after the booster vaccination. This criterion is applicable only for those subjects who receive a booster dose.
    Prior to receipt of booster vaccination during Ad hoc Clinic Visit, subjects must be evaluated to confirm that they are eligible. If subjects do not meet any of the original inclusion criteria listed above, they should not receive booster dose of rabies vaccine.
    E.4Principal exclusion criteria
    Prior to extension study entry, each subject must not have:
    1. Completed the parent study V49_23 without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen.
    2. History of exposure to suspected or confirmed rabid animal.
    3. Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of V49_23 study.
    4. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
    5. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
    6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study.
    7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study.
    8. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study.
    9. Study personnel as well as their immediate family or household member.
    10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

    Prior to Scheduled Visit, each subject must not have:
    1. History of exposure to suspected or confirmed rabid animal.
    2. Receipt of rabies immunoglobulins, non-study rabies vaccine following completion of V49_23 study.
    3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
    4. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
    5. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study.
    6. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study.
    7. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study.
    8. Study personnel as well as their immediate family or household member.
    9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

    Prior to booster vaccination, each subject eligible for booster vaccination (i.e., subjects with RVNA concentrations <0.5 IU/mL at the first visit of this extension study [Day 1, Year 3] or at the following year visits [Year 4 to Year 9]) should be in good health status and must not have none of the following:
    1. Progressive, unstable or uncontrolled clinical conditions.
    2. Abnormal function of the immune system resulting from:
    a. Clinical conditions.
    b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to the Ad hoc visit or receipt or planning to receive them during the participation to the study.
    c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to the Ad hoc visit or receipt or planning to receive them during the participation to the study.
    3. Receipt of non-study rabies vaccine.
    4. Receipt of any other vaccines within 28 days prior to the booster dose or planning to receive any vaccine within 28 days from the booster dose.
    5. Receipt of any investigational or non-registered medicinal product within 14 days before booster dose till next Scheduled Clinic Visit after booster dose administration.
    6. Receipt of anti-malarial medications (e.g. Mefloquine) within 14 days before booster dose till next Scheduled Clinic Visit after booster dose administration.
    Prior to receipt of booster study vaccination, subjects must be evaluated to confirm that they are in good health and they are eligible for subsequent vaccination. If subjects meet any of the original exclusion criteria listed above, they should not receive additional vaccinations.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints:
    The primary immunogenicity endpoints will be based on the RVNA concentrations at Year 3, 4, 5, 6, 7, 8, 9 and 10 following a primary series of accelerated or conventional rabies PrEP IM regimen during the parent study V49_23, as measured by rapid
    fluorescent focus inhibition test (RFFIT). RFFIT assays will be performed at a delegate, qualified laboratory, as specified by GSK.
    Measures of immunogenicity will be summarized by the vaccination regimen received in the parent study V49_23, as follows:
    -Time to first RVNA concentrations < 0.5 IU/mL.
    - Geometric Mean Concentrations (GMCs) and Geometric Mean Ratios (GMRs) for subjects receiving the booster dose, as measured by antibody concentration at 7 days after the booster dose vs. antibody concentration before the booster dose.
    Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at 7 days after the booster dose and at subsequent Scheduled Clinic Visits.

    Safety Endpoint:
    For subjects receiving PCEC rabies booster vaccination, Serious Adverse Events (SAEs) and the associated concomitant medications will be collected starting from the booster administration and until the day of next Scheduled Clinic Visit.
    Number and percentages of SAEs will be summarized only for subjects receiving a booster dose by the vaccination regimen received in the parent study V49_23 and overall.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Year 3, 4, 5, 6, 7, 8, 9 and 10.
    E.5.2Secondary end point(s)
    Immunogenicity Endpoints:
    - Geometric Mean Antibody Concentrations (GMCs) at Year 3, 4, 5, 6, 7, 8, 9 and 10;
    - Reverse Cumulative Distribution Plots (RCDPs) at Year 3, 4, 5, 6, 7, 8, 9 and 10;
    - Percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL, as measured by RFFIT assay at Year 3, 4, 5, 6, 7, 8, 9 and 10.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Year 3, 4, 5, 6, 7, 8, 9 and 10.
    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
    Immunogeneicity and boostability of immune responses.
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Germany
    Switzerland
    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
    The date of termination is the date of the last contact (clinic visit) in which the subject’s health status was assessed or, in cases where the subject does not agree to any further safety follow-up or blood draw; it is the date consent is withdrawn.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 578
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 578
    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)
    After the subject has ended the participation in this trial they will continue with standard 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 Decision2015-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-15
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