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    Summary
    EudraCT Number:2016-000290-20
    Sponsor's Protocol Code Number:204889
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-09-22
    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 number2016-000290-20
    A.3Full title of the trial
    Phase IIb randomized, open-label, controlled, multi-center study of the efficacy, safety and immunogenicity of GSK Biologicals’ candidate malaria vaccine RTS,S/AS01E evaluating schedules with or without fractional doses, early Dose 4 and yearly doses, in children 5-17 months of age living in sub-Saharan Africa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety and immunogenicity study of GSK Biologicals’ candidate malaria vaccine (SB257049) evaluating schedules with or without fractional doses, early Dose 4 and yearly doses, in children 5-17 months of age
    A.3.2Name or abbreviated title of the trial where available
    MALARIA-094
    A.4.1Sponsor's protocol code number204889
    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
    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
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportProgram for Appropriate Technology in Health (PATH)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    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 number442089904466
    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 No
    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 nameCandidate Plasmodium falciparum malaria vaccine
    D.3.2Product code RTS,S+AS01E
    D.3.4Pharmaceutical form Powder and suspension for suspension 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 INN-
    D.3.9.2Current sponsor codeRTS,S
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 holderGSK Vaccines GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    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
    Healthy volunteers (primary immunization against malaria disease caused by Plasmodium falciparum)
    E.1.1.1Medical condition in easily understood language
    Malaria
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025487
    E.1.2Term Malaria
    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
    To demonstrate the superiority of a 3-dose schedule of GSK Biologicals’ malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 compared to a standard schedule of RTS,S/AS01E with three full doses in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.

    E.2.2Secondary objectives of the trial
    To assess the incremental vaccine efficacy against clinical malaria of a schedule with a:
    -fractional third dose at Month 2 versus 3 full doses.
    -fractional third dose at Month 7 versus a fractional third dose at month 2 or 3 full doses.
    -fractional third dose at month 2 and yearly fractional doses versus full doses and yearly full doses.
    -fractional third dose at Month 7 versus a standard schedule with 4 full doses at 0,1,2,20 months.
    To assess:
    -the VE and impact of each schedule.
    -the prevalence of P. falciparum infections of each schedule at cross-sectional visits.
    -the VE against incident P. falciparum infections defined by positive blood slide.
    To describe the antibody response to the anti-circumsporozoite protein of P. falciparum (anti-CS) and hepatitis B surface antigen (anti-HBs) for each schedule.
    To assess the safety in terms of SAEs, unsolicited adverse events (AEs) and AEs of specific interest, local and general AEs, haemtology and biochemistry parameters.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    206213 (MALARIA-095): Molecular detection and genotyping of Plasmodium falciparum parasites in young African children after immunization with RTS,S/AS01E malaria vaccine
    Protocol 08-May-2017
    Primary Objective: To estimate and compare vaccine efficacy against new malaria infection(s) across all genotypes among the vaccine arms of the trial, using amplicon sequencing and genotyping to detect new infections. Asymptomatic P falcipa-rum infections will be detected in monthly cross-sectional samples and clinical infection will be detected by passive case detection.
    E.3Principal inclusion criteria
    Subjects’ parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the require-ments of the protocol (e.g. return for follow-up visits).
    • Signed or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independ-ent witness.
    • A male or female between, and including, five and 17 months of age at the time of the first vaccination.
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • Previously received three documented doses of diph-theria, tetanus, pertussis, hepatitis B vaccine (DTPHepB), and at least three doses of oral polio vaccine.
    E.4Principal exclusion criteria
    • Child in care.
    • Use of a drug or vaccine that is not approved for that indication (by one of the following regulatory authorities: Food and Drug Administration [FDA; USA] or European Union member state or WHO [with respect to prequalifi-cation]) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
    • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
    • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day (for pediatric subjects) or equivalent. Inhaled and topical steroids are allowed.
    • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before each dose and ending seven days after each dose of vaccine administration.
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    • Family history of congenital or hereditary immunodeficiency.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
    • History of anaphylaxis post-vaccination.
    • History of any, or documented, serious adverse reaction to rabies vaccination.
    • Contraindication to rabies vaccination (Rabipur is contra-indicated in subjects with an history of a severe hyper-sensitivity to any of the ingredients in the vaccine. Note that the vaccine contains polygeline and residues of chicken proteins, and may contain traces of neomycin, chlortetracycline and amphotericin B).
    • Major congenital defects.
    • Serious chronic illness.
    • Children with a past history of a neurological disorder or atypical febrile seizure (a febrile seizure is atypical if it meets one of the following criteria: not associated with fever; lasts > 5 minutes; focal (not generalized); followed by transient or persistent neurological abnormality; occurs in a child < 6 months of age).
    • Acute disease and/or fever at the time of enrolment.
     Fever is defined as temperature ≥ 37.5C/99.5F for oral, axillary or tympanic route, or ≥ 38.0C/100.4F for rectal route.
     Subjects with a minor illness (such as mild diar-rhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
    • Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
    • Moderate or severe malnutrition at screening defined as weight for age or weight for height Z-score < -2.
    • Hemoglobin concentration < 8 g/dl at screening.
    • Same sex twins (to avoid misidentification).
    • Maternal death.
    • Prior receipt of an investigational malaria vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    The occurrence of clinical malaria meeting the primary case definition
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Month 2.5 up to Month 14
    E.5.2Secondary end point(s)
    The occurrence of clinical malaria meeting the primary and secondary case definitions
    The occurrence of incident P. falciparum infections
    The prevalence of P. falciparum infections defined by positive blood slide at each cross-sectional survey
    Number of seropositive subjects for anti-CS antibodies and anti-HBs antibodies, antibody concentrations for anti-CS and anti-HBs (in a sub-cohort of first 25 subjects enrolled in each group per site)
    Number of subjects with any, fatal and related SAEs, with any AE and SAE leading to withdrawal from further vaccination, with severe malaria, cerebral malaria, potential Immune mediated diseases (pIMDs), meningitis
    Number of subjects with seizures
    Number of subjects with generalized convulsive seizures
    Number of subjects with any unsolicited AE(s)
    Number of subjects with abnormal laboratory values (in a sub-cohort of first 25 subjects enrolled in each group per site)
    Number of subjects with any solicited local and general symptoms (in the reactogenity sub-cohort of first 25 subjects en-rolled per site)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0-Month 50
    Day 0-Month 50
    Monthly from Month 0-20; every 3months thereafter till Month 50
    Before Dose 1, 1 month post-Dose 2 (group Fx017-mFxD only), before and 1 month post-Dose 3, before and 1 month after Dose 4, before and 1 month after each yearly dose and at Month 50
    Day 0-Month 50
    During 30-day follow up period after each dose of study vaccine
    During 7-day follow up period after each dose of study vaccine
    During 30-day follow up period after each dose of study vaccine
    Before Dose 3, 7 days post-Dose 3, 30 days post-Dose 3
    During the 7-day (Days 0-6) follow-up period after each vaccination
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial5
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    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
    Ghana
    Kenya
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial 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: 1500
    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: 1500
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    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 No
    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 1500
    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)
    No plan for treatment or care after the subject has ended the participation in this trial is provided for prophylactic vaccine studies as the subjects are healthy and do not need any treament or care after end of the study.
    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: Ghana
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