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    Summary
    EudraCT Number:2013-003768-30
    Sponsor's Protocol Code Number:114778
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 number2013-003768-30
    A.3Full title of the trial
    A phase IV, single-blind, randomized, multicenter study to assess the immunogenicity and safety of GSK Biologicals’ dTpa vaccine (Boostrix™) using a new syringe presentation in healthy adolescents aged 10–15 years.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety of BoostrixTM using a new syringe in 10 to 15-year-old adolescents.
    A.3.2Name or abbreviated title of the trial where available
    DTPA (BOOSTRIX)-045
    A.4.1Sponsor's protocol code number114778
    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 I'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.3.4Pharmaceutical 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 codeD
    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 codeT
    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 number20
    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
    Booster immunization of healthy adolescents against diphtheria, tetanus and pertussis.
    E.1.1.1Medical condition in easily understood language
    Diphtheria, tetanus (lock jaw) and pertussis (Whooping cough)
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    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 that Boostrix administered using the new syringe presentation is non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to all vaccine antigens, one month after booster vaccination.
    E.2.2Secondary objectives of the trial
    •To assess the immunogenicity to the study vaccines in terms of seroprotection or seropositivity rates, one month after booster vaccination.
    •To assess the immune response to the study vaccines in terms of booster response to diphtheria, tetanus and pertussis antigens, one month after booster vaccination.
    •To assess the safety and reactogenicity of the study vaccines in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subject’s parent(s)/Legally Acceptable Representative(s) [LAR(s)] and subjects who the investigator believes can and are willing to comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
    •A male or female between 10 and 15 years of age (from and including the 10th birthday up to but excluding the 16th birthday) at the time of booster vaccination.
    •Prior to protocol amendment 2, subjects who have previously received 5 doses of DTP (w/a) as part of primary and booster vaccination, in line with local recommendations.
    •After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.
    •Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.
    •Written informed consent to be obtained before study entry from the parent(s)/LAR(s) of the subject.
    •Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s), if required by local regulations.
    •Female subjects of non-childbearing potential may be enrolled in the study.
    -Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
    •Female subjects of childbearing potential may be enrolled in the study, if the subject:
    -has a negative pregnancy test on the day of vaccination; and
    -if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.
    E.4Principal exclusion criteria
    •Child in care.
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone < 20 mg/day or equivalent, inhaled and topical steroids are allowed.
    •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose.
    •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 product (pharmaceutical product or device).
    •A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
    •A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months .
    •Occurrence of any of the following adverse event after a previous administration of a Boostrix vaccine :
    -known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines,
    -encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
    -transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine (including latex).
    •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    •Acute disease and/or fever at the time of enrolment.
    -Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. The preferred route for recording tempera-ture in this study will be oral or axillary.
    -Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection), without fever, may be enrolled at the discretion of the investigator.
    •Pregnant or lactating female.
    •Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to components of the study vaccine.
    -Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after booster vaccination (Month 1).
    E.5.2Secondary end point(s)
    Immunogenicity with respect to the components of the study vaccines.
    Booster response to all vaccine antigens.
    Occurrence of solicited local and general symptoms.
    Occurrence of unsolicited symptoms and Serious Adverse Events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity with respect to the components of the study vaccines-Prior to and one month after booster vaccination.
    Booster response to all vaccine antigens-One month after booster vaccination.
    Occurrence of solicited local and general symptoms-During the 4-day (Day 0–Day 3) follow-up period after booster vaccination.
    Occurrence of unsolicited symptoms and Serious Adverse Events-During the 31-day (Day 0–Day 30) follow up period after booster vaccination.
    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 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) 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    New or previous syringe presentation
    E.8.2.4Number of treatment arms in the trial2
    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
    Chile
    Mexico
    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
    LVLS
    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 months3
    E.8.9.2In all countries concerned by the trial days2
    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: 671
    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: 671
    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 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 671
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Mexico
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