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    Summary
    EudraCT Number:2015-003405-42
    Sponsor's Protocol Code Number:201532
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-01-16
    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 number2015-003405-42
    A.3Full title of the trial
    A phase III, open-label, single-group, multi-centre study to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ combined reduced antigen content diphtheria, tetanus and acellular pertussis (dTpa) vaccine, Boostrix, administered as a booster dose in healthy Russian subjects aged four years and older.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of immunogenicity, safety and reactogenicity of GSK Biologicals’ dTpa booster vaccine (263855) (Boostrix) administered as a booster dose in healthy Russian subjects.
    A.3.2Name or abbreviated title of the trial where available
    DTPA (BOOSTRIX)-050
    A.4.1Sponsor's protocol code number201532
    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.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 Yes
    D.2.1.1.1Trade name Boostrix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    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.3.1Product nameBoostrix
    D.3.2Product code dtPa
    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 INN-
    D.3.9.2Current sponsor codeDT
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeTT
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    D.3.9.4EV Substance CodeSUB14817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive nameFILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB38509
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePERTUSSIS PERTACTIN
    D.3.9.4EV Substance CodeSUB20527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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 [Booster immunisation against diphtheria, tetanus and pertussis diseases of individuals from age of four years onwards. The study population for this study will include individuals aged four years and above.
    E.1.1.1Medical condition in easily understood language
    Diphtheria
    Lock jaw
    Whopping cough
    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 SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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 assess the immune response to the dTpa vaccine in terms of seroprotection status for antibodies against diphtheria and tetanus antigens and in terms of seropositivity status for anti-bodies against the pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)], one month after vaccination.
    E.2.2Secondary objectives of the trial
    • To assess the immune response in terms of booster response to diphtheria, tetanus, PT, FHA, and PRN antigens, one month after vaccination.
    • To assess the immune response in terms of antibody concentrations to diphtheria, tetanus, PT, FHA, and PRN antigens, one month after vaccination.
    • To assess the reactogenicity and safety of Boostrix in terms of solicited symptoms (local and general), unsolicited adverse events (AEs) and serious adverse events (SAEs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects or subjects’ parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • A male or female four years of age and older.
    • Written informed consent obtained from the subject/from the parent(s)/ adoptive parent(s) of the subject prior to performing any study specific procedure.
    • Written informed assent obtained from subjects aged 14 years to <18 years.
    • Healthy subjects as established by medical history and physical examination before entering into the study.
    • Children four to seven years of age who have received diphtheria, tetanus and pertussis vaccination prior to study enrolment as per local recommendations.
    • Subjects eight years of age and older who have received diphtheria, tetanus and pertussis vaccination to the best of their/subjects’ parent(s)/subjects’ adoptive parent(s) knowledge and did not receive an additional diphtheria, tetanus or pertussis vaccination within 5 years prior to enrolment in the study will be enrolled.
    •Female subjects of non-childbearing potential may be enrolled in the study.
    Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
    •Female subjects of childbearing potential may be enrolled in the study, if the subject:
    -has practiced adequate contraception within 30 days prior to vaccination, and
    -has a negative pregnancy test on the day of vacci-nation, and
    -has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccination.
    E.4Principal exclusion criteria
    • Child in care
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
    • History of previous or intercurrent diphtheria, tetanus or pertussis diseases since birth in subjects four to seven years of age.
    • History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5 years prior to enrolment in subjects aged eight years and above.
    • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), or equivalent. Inhaled and topical steroids are allowed
    • Administration of long-acting immune-modifying drugs at any time during the study period.
    • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccine with the exception of inactivated influenza vaccine which can be given at any time during the study conduct as per the Summary of Product Characteristics (SPC) or PI and according to the local governmental recommendations.
    • 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.
    • Family history of congenital or hereditary immunodeficiency.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    • Hypersensitivity to latex.
    • History of encephalopathy after administration of a previous dose of pertussis vaccine that could not be attributed to another identifiable cause, progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
    • Acute disease and/or fever at the time of enrolment.
    Fever is defined as temperature >= 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the axilla.
    Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
    • Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    • Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
    • Pregnant or lactating female.
    • Female planning to become pregnant or planning to discontinue contraceptive precautions during the study conduct.
    • Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
    • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
    E.5 End points
    E.5.1Primary end point(s)
    • Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T).
    A seroprotected subject is a subject whose anti-D and anti-T concentrations are ≥ 0.1 IU/ml.

    • Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).
    A seropositive subject is a subject whose antibody concentration is greater than or equal to the assay cut-off value.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 31
    E.5.2Secondary end point(s)
    • Booster response to the D, T, PT, FHA and PRN antigens
    Booster response to D and T antigens is defined as:
    - for initially seronegative subjects (pre-vaccination concentration below cut-off:
    < 0.1 IU/ml): antibody concentrations at least four times the cut-off (post-vaccination concentration >= 0.4 IU/ml), and
    - for initially seropositive subjects (pre-vaccination concentration >= 0.1 IU/ml): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.
    Booster response to PT, FHA and PRN antigens is defined as:
    - for subjects with pre-vaccination antibody concentration < 5 EL.U/ml: antibody concentration >= 20 EL.U/m;
    - for subjects with pre-vaccination antibody concentration >= 5 EL.U/ml and
    < 20 EL.U/ml: antibody concentration at least 4 times the pre-vaccination concentration; and
    - for subjects with pre-vaccination antibody concentration 20 EL.U/ml: antibody concentration at least two times the pre-vaccination concentration.
    • Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations
    Concentrations are expressed as geometric mean concentra-tions (GMCs).
    • Number of subjects with solicited local and general symptoms
    Occurrence of each solicited local and general symptom and occurrence of large swelling reactions.
    • Number of subjects with unsolicited adverse events (AEs)
    An unsolicited AE was defined as Any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
    • Number of subjects with serious adverse events (SAEs)
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 31
    Day 31
    During the 4-day (Day 1–4) follow-up period after vaccination
    During the 31-day (Day 1–31) follow-up period after vaccination
    From Day 1 to Day 31
    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 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 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.8.2.4Number of treatment arms in the trial1
    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
    Russian Federation
    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
    Last testing results released of samples collected at Visit 2
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 224
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 112
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 112
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 448
    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 GlaxoSmithKline Biologicals
    G.4.3.4Network Country Belgium
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Russian Federation
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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