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    Summary
    EudraCT Number:2021-000891-12
    Sponsor's Protocol Code Number:212149
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-26
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-000891-12
    A.3Full title of the trial
    A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei and S. flexneri, serotypes 1b, 2a, and 3a, in adults in Europe (Stage 1) followed by age de-escalation from adults to children and infants, and dose-finding in infants in Africa (Stage 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the safety and immune responses to the GVGH altSonflex1-2-3 vaccine against shigellosis in adults, children, and infants
    A.3.2Name or abbreviated title of the trial where available
    SHIGELLA 4 GMMA GVGH-001 (H06_01TP)
    A.4.1Sponsor's protocol code number212149
    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.1.3.4CountryItaly
    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 supportBill & 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 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 nameShigella sonnei, Shigella flexneri 1b, 2a, 3a GMMA vaccine
    D.3.2Product code altSonflex1-2-3 (GSK4001785A)
    D.3.4Pharmaceutical form 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 INNNot applicable
    D.3.9.2Current sponsor codeShigella sonnei 2929-GMMA
    D.3.9.3Other descriptive name2929-GMMA
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeShigella flexneri 1b 2858-GMMA
    D.3.9.3Other descriptive name2858-GMMA
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeShigella flexneri 2a 2404-GMMA
    D.3.9.3Other descriptive name2404-GMMA
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeShigella flexneri 3a 2766-GMMA
    D.3.9.3Other descriptive name2766-GMMA
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a.
    E.1.1.1Medical condition in easily understood language
    Prevention of diarrhoeal disease due to Shigella infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10040550
    E.1.2Term Shigella infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10054178
    E.1.2Term Shigella infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040542
    E.1.2Term Shigella
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040547
    E.1.2Term Shigella flexneri
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040551
    E.1.2Term Shigella sonnei
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10004016
    E.1.2Term Bacterial diarrhoea
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012735
    E.1.2Term Diarrhoea
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To identify the preferred dose of each component of the altSonflex1-2-3 vaccine (low, medium, or high) for infants 9 months of age in Africa (Stage 2).
    • To evaluate the safety and reactogenicity of the altSonflex1-2-3 vaccine in all participants in Europe and Africa (Stage 1 and Stage 2).
    E.2.2Secondary objectives of the trial
    • To evaluate the immunogenicity profile of the altSonflex1-2-3 vaccine in all participants in Europe (Stage 1).
    • To evaluate the immunogenicity profile of the altSonflex1-2-3 vaccine in all participants in Africa (Stage 2).
    • To further characterise the immunogenicity profile of the S. sonnei component of altSonflex1-2-3 vaccine in all participants in Europe and Africa (Stage 1 and Stage 2).
    • To evaluate seroresponse with the altSonflex1-2-3 vaccine after each vaccination in all participants in Europe and Africa (Stage 1 and Stage 2).
    • To evaluate the immunogenicity of co-administered MR-VAC in infants 9 months of age in Africa (Stage 2), in the dose-finding cohort.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All participants:
    •Participants and/or participants’ parent(s)/legally acceptable representative(s) LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
    •Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
    •Healthy participants as established by medical history, clinical examination, and laboratory assessment.
    •Participants satisfying all screening requirements.
    •Participants seronegative for hepatitis B, and hepatitis C.
    •Participants negative for human leukocyte antigen B27 (HLA-B27).
    Adults 18 to 50 years of age:
    •A male or female between, and including, 18 and 50 years of age at the time of the first study intervention administration.
    •Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
    •Female participants of childbearing potential may be enrolled in the study, if the participant:
    -has practiced adequate contraception for 1 month prior to study intervention administration, and
    -has a negative pregnancy test on the day of study intervention administration, and
    -has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
    •Participants seronegative for human immunodeficiency virus (HIV)
    Children 24 to 59 months of age:
    •A male or female between, and including, 24 and 59 months of age at the time of first vaccination.
    •Normal nutritional Z score (-2 standard deviation or greater)
    •Previously completed routine childhood vaccinations to the best knowledge of the participant’s parent(s)/LAR(s).
    •Born after gestation period of ≥37 weeks
    •Participants seronegative for HIV
    Infants 9 months of age:
    •A male or female 9 months of age at the time of first vaccination.
    •Normal nutritional Z score (-2 standard deviations or greater).
    •Previously completed routine childhood vaccinations to the best knowledge of the participant’s parent(s)/LAR(s).
    •Born after a gestation period of ≥37 weeks
    •Participants negative for HIV as confirmed by deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) testing
    E.4Principal exclusion criteria
    All participants:
    •Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant or documented by patient records (e.g., history of microbiologically-confirmed Shigella infection), recent travel* (within 2 years) to a s country where Shigella or other eneteric infections are endemic, or recent occupation* (within 3 years) involving Shigella species.
    •Progressive, unstable or uncontrolled clinical conditions.
    •History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    •Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
    •Clinical conditions representing a contraindication to IM vaccination and blood draws.
    •Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the study.
    •Acute disease and/or fever (defined as temperature 38.0°C) at the time of enrolment*.
    *The participant can still be enrolled into the study at a time when the acute disease and/or fever has resolved.
    •Any clinically significant haematological and/or biochemical laboratory abnormality.
    •Confirmed positive COVID-19 test during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1)
    •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
    •Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
    •Prior receipt of an experimental Shigella vaccine or live Shigella challenge.
    •Use of any investigational or non-registered product (drug, vaccine or medical device)* other than the study vaccine during the period starting 30 days before the first dose of study intervention (Day -30 to Day 1), or planned use during the study period.
    *Use of herbs and traditional treatments is not considered an exclusion criterion
    •A vaccine not foreseen* by the Study Protocol administered during the period starting at -21 days before the first dose (-28 days in the case of live vaccines) and ending after the last dose of study intervention administration**.
    •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).
    •Any study personnel or immediate dependents, family, or household member.
    Adults 18 to 50 years of age:
    •Acute or chronic illness, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    •Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine study intervention. For corticosteroids, this will mean prednisone equivalent greater than or equal to 20 mg/day for adult participants. Inhaled and topical steroids are allowed.
    •Pregnant or lactating female.
    •Female planning to become pregnant or planning to discontinue contraceptive precautions.
    •History of or current chronic alcohol consumption and/or drug abuse.
    Children 24 to 59 months of age and infants 9 months of age:
    •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone equal or greater than 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for paediatric participants. Inhaled and topical steroids are allowed.
    •Child in care.
    Children 24 to 59 months of age:
    •Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
    Infants 9 months of age:
    •Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, from birth or planned administration during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    A. Anti-serotype specific Shigella lipopolysaccharide (LPS) serum immunoglobulin G (IgG) titers in infants 9 months of age in Africa
    B. Number of adults 18 to 50 years of age in Europe with solicited administration site events
    C. Number of adults 18 to 50 years of age in Europe with solicited systemic events
    D. Number of adults 18 to 50 years of age in Europe with unsolicited adverse events (AEs)
    E. Number of adults 18 to 50 years of age in Europe with serious adverse events (SAEs)
    F. Number of adults 18 to 50 years of age in Europe with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8
    G. Number of adults 18 to 50 years of age in Europe with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92/Day 176
    H. Number of adults 18 to 50 years of age in Africa with solicited administration site events
    I. Number of adults 18 to 50 years of age in Africa with solicited systemic events
    J. Number of adults 18 to 50 years of age in Africa with unsolicited AEs
    K. Number of adults 18 to 50 years of age in Africa with SAEs
    L. Number of adults 18 to 50 years of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration)
    M. Number of adults 18 to 50 years of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration)
    N. Number of children 24 to 59 months of age in Africa with solicited administration site events
    O. Number of children 24 to 59 months of age in Africa with solicited systemic events
    P. Number of children 24 to 59 months of age in Africa with unsolicited AEs
    Q. Number of children 24 to 59 months of age in Africa with SAEs
    R. Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration)
    S. Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration)
    T. Number of infants 9 months of age in Africa with solicited administration site events
    U. Number of infants 9 months of age in Africa with solicited systemic events
    V. Number of infants 9 months of age in Africa with unsolicited AEs
    W. Number of infants 9 months of age in Africa with SAEs
    X. Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration)
    Y. Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration)
    Z. Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 260 (7 days after the third study intervention administration)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 281 (A)
    During 7 days after each study intervention administration (B, C, H, I, N, O, T, U)
    During 28 days after each study intervention administration (D, J, P, V)
    During the entire study participation period (E, K, Q, W)
    At Day 8 (F, L, R, X)
    At Day 92/Day 176 (G)
    At Day 92 (M, S, Y)
    At Day 260 (Z)
    E.5.2Secondary end point(s)
    A.Anti-serotype specific Shigella LPS/OAg serum IgG geometric mean concentrations (GMCs) in adults 18 to 50 years of age in Europe

    B. Anti-serotype specific Shigella LPS serum IgG GMTs in adults 18 to 50 years of age in Africa

    C. Anti-serotype specific Shigella LPS serum IgG GMTs in children 24 to 59 months of age in Africa

    D. Anti-serotype specific Shigella LPS serum IgG GMTs in infants 9 months of age in Africa

    E. Number of adults 18 to 50 years of age in Europe achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS

    F. Number of adults 18 to 50 years of age in Africa achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS

    G. Number of children 24 to 59 months of age in Africa achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS

    H. Number of infants 9 months of age in Africa achieving an ELISA level equivalent to ≥1:800 titer against S. sonnei LPS

    I.Number of adults 18 to 50 years of age in Europe achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS

    J. Number of adults 18 to 50 years of age in Africa achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS

    K. Number of children 24 to 59 months of age in Africa achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS

    L. Number of infants 9 months of age in Africa achieving an ELISA level equivalent to ≥1:1600 titer against S. sonnei LPS

    M. Number of adults 18 to 50 years of age in Europe showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations

    N. Number of adults 18 to 50 years of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers

    O. Number of children 24 to 59 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers

    P. Number of infants 9 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS serum IgG titers

    Q. Anti-measles IgG concentrations in infants 9 months of age in the dose-finding groups in Africa

    R. Anti-rubella IgG concentrations in infants 9 months of age in the dose-finding groups in Africa

    S. Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-measles IgG concentrations of ≥150 mIU/mL and ≥200 mIU/mL

    T. Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-rubella IgG concentrations of ≥4 IU/mL and ≥10 IU/mL
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 1 and Day 85/Day 169, at Day 15 and at Day 29 and Day 113/Day197 (A, E, I)

    At Day 1 and Day 85 and at Day 29 and Day 113 (B, C, F, G, J, K)

    At Day 1, Day 85 and Day 253 and at Day 29, Day 113 and Day 281 (D, H, L)

    At Day 15 and at Day 29 and Day 113/197 compared to Day 1 and Day 85/Day 169 (M)

    At Day 29 and Day 113 compared to Day 1 and Day 85 (N, O)

    At Day 29, Day 113 and Day 281 compared to Day 1, Day 85 and Day 253 (P)

    At Day 1 and Day 281 (Q, R)

    At Day 281 (S, T)
    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 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 and dose selection
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    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.8.1.7.1Other trial design description
    Observer-blind (a type of double blinding)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    MENVEO, INFANRIX, BOOSTRIX, TYPHIM VI
    E.8.2.4Number of treatment arms in the trial20
    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 No
    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
    Kenya
    Belgium
    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
    Date of last testing/reading released of the Human Biological Samples or imaging data, related to primary and secondary endpoints. End of Study must be achieved no later than 8 months after Last Subject Last Visit (LSLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years3
    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: 428
    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: 388
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    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: 122
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In trial stage 1 in Belgium, all participants will be capable of giving consent personally.
    In trial stage 2 in Kenya, parent / Legally Accepted Representative will give consent on behalf of children / infants.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state102
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 550
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Keyrus Life Science
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
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