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    Summary
    EudraCT Number:2013-003429-28
    Sponsor's Protocol Code Number:109823
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-06
    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 ConcernedEstonia - SAM
    A.2EudraCT number2013-003429-28
    A.3Full title of the trial
    A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) administered intramuscularly according to a three-dose schedule (Day 0, Week 6, Month 6) in human immunodeficiency virus-infected (HIV+) female subjects aged 15 - 25 years, as compared to Merck’s HPV-6/11/16/18 vaccine (Gardasil®).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of safety and immunogenicity of a Human Papillomavirus (HPV) vaccine in human immunodeficiency virus (HIV) infected females.
    A.3.2Name or abbreviated title of the trial where available
    HPV-019 PRI
    A.4.1Sponsor's protocol code number109823
    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 Cervarix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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.3.9.3Other descriptive nameHuman Papillomavirus 1 type 16 L1 protein
    D.3.9.4EV Substance CodeSUB38470
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameHuman Papillomavirus 1 type 18 L1 protein
    D.3.9.4EV Substance CodeSUB38471
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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 RoleComparator
    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 Gardasil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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.3.9.3Other descriptive nameHPV 6 TYPE L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25327
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameHPV TYPE 11 L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25330
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameHPV TYPE 16 L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25329
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameHPV TYPE 18 L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25328
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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
    For active immunization of women from the age of 10 years onwards to prevent cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC US) and cervical intraepithelial neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and CIN 3), caused by oncogenic HPV types 16 and 18.
    E.1.1.1Medical condition in easily understood language
    Cervarix is a vaccine that protects women against infection caused by HPV type 16 and type 18. These viruses can infect the skin or the genitals, which can lead to cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10071147
    E.1.2Term Human papilloma virus immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10058580
    E.1.2Term Human papilloma virus serology test
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the safety and reactogenicity of both vaccines in HIV+ subjects for up to one month after the third dose of vaccine.
    - To demonstrate non-inferiority of Cervarix versus (vs.) Gardasil in terms of geometric mean titers (GMTs) against HPV-16 and HPV-18 measured by Pseudovirion-based neutralization assay (PBNA) one month after administration of the third dose of vaccine in HIV+ subjects.
    - If the first primary objective for immunogenicity is demonstrated, superiority of Cervarix over Gardasil in terms of GMTs against HPV-16 and HPV-18 measured by PBNA in HIV+ subjects will be assessed following a sequential approach.
    - First, superiority for HPV-18 will be assessed.
    - Second, if superiority for HPV-18 is shown, superiority for HPV-16 will be assessed.
    E.2.2Secondary objectives of the trial
    - To demonstrate superiority of Cervarix vs. Gardasil in terms of GMTs against HPV-16 or HPV-18 measured by PBNA 1 month (M) after the administration of the 3rd dose of vaccine in HIV- subjects.
    - To evaluate the antibody response of both vaccines with respect to HPV-16 and HPV-18 antibody levels by ELISA at Day 0, Week (W)6, W 10, M 7, 12, 18 and 24 in all subjects.
    - To evaluate antibody response, by ELISA, against HPV-16 and HPV-18 in CVS at Day 0, W 6, W 10, M 7, 12 and 24 in post-menarcheal subjects who volunteer for this procedure.
    - To evaluate memory B and T cell-mediated immune (CMI) response against HPV-16 and HPV-18 at Day 0, W 6, W 10, M 7 and 12 in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
    - To evaluate the safety and reactogenicity of both vaccines in HIV- subjects for up to 1M after the 3rd dose of vaccine and in all subjects for up to 24 M after the Iast vaccine dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
    •A female between, and including, 15 and 25 years of age at the time of the first vaccination.
    •Written informed consent obtained from the subject and/or from the subject’s parent or LAR.
    •Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status.
    •For HIV seropositive subjects:
    -Subjects must be HIV seropositive according to World Health Organization (WHO) case definition.
    -Subject must be asymptomatic (or only have persistent generalized lymphadenopathy).
    -Subjects should have a CD4 cell count > 350 cells/mm3.
    -If currently taking antiretrovirals (ARVs), subjects must be on compliant to triple therapy (highly active ART) and have undetectable viral load on two previous clinical visits within the six months prior to study entry.
    •For HIV seronegative subjects:
    -Subjects confirmed as HIV seronegative at the screening visit.
    •For non-virgin female subjects:
    -Subjects must have no history of abnormal cytology or CIN 1/2/3.
    -Subjects must have had no more than six life-time sexual partners prior to enrollment.
    •Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures involving damage to the transformation zone of the cervix or stenosis.
    •Female subjects of non-childbearing potential may be enrolled in the study.
    •Female subjects of childbearing potential may be enrolled in the study, if the subject:
    -has practiced adequate contraception for 30 days prior to vaccination, and
    -has a negative pregnancy test at screening and on the day of vaccination, and
    -has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
    E.4Principal exclusion criteria
    •Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 24).
    •ART not compliant with the National Guidelines.
    •Active tuberculosis (TB) visit (criteria mandatory only for HIV+ subjects).
    •Current TB therapy.
    •Hemoglobin < 8.0 g/dL at the screening visit.
    •Creatinine > 1.5-fold the upper limit of normal (ULN) at the screening visit.
    •Alanine aminotransferase (ALT) > 2.5-fold ULN at the screening visit.
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (Day 0 to Month 24).
    •Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs (with the exception of ART) within six months prior to the first vaccine dose.
    •Administration of a vaccine not foreseen by the study protocol within 30 days (Days 0 - 29) before the first dose of study vaccine/control. Enrollment will be postponed until the subject is outside the specified window.
    •Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0 - 29) any dose of study vaccine.
    •Previous administration of components of the investigational vaccine.
    •Cancer or autoimmune disease under treatment.
    •Hypersensitivity to latex.
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.
    •Acute disease and/or fever at the time of enrollment.
    •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
    •History of any neurological disorders or seizures.
    •Pregnant or breastfeeding female.
    •A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e., up to Month 8).
    •Concurrently participating in another clinical study, at any time during the study period (Day 0 to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product.
    •Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.
    •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrollment will be postponed until the subject is outside the specified window.
    •Administration of trimethoprim/sulphamethoxazole within seven days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within seven days after the first dose of study vaccine/control.
    •Current drugs or alcohol abuse.
    •Child in care.
    E.5 End points
    E.5.1Primary end point(s)
    - Occurrence and intensity of solicited local symptoms in HIV+ subjects.
    - Occurrence, intensity and relationship to vaccination of solicited general symptomsin HIV+ subjects.
    - Occurrence, intensity and relationship to vaccination of unsolicited symptoms in HIV+ subjects.
    - Occurrence of SAEs up to 30 days after the last dose of vaccine in HIV+ subjects.
    - Occurrence of medically significant conditions (including potential immune mediated diseases) up to 30 days after the last dose of vaccine in HIV+ subjects.
    - Occurrence and outcome of pregnancies up to 30 days after the last dose of vaccine in HIV+ subjects.
    - Occurrence of clinically relevant abnormalities in hematological and biochemical parameters up to 30 days after the last dose of vaccine in HIV+ subjects.
    - CD4 cell count up to 30 days after the last dose of vaccine in HIV+ subjects.
    - HIV viral load up to 30 days after the last dose of vaccine in HIV+ subjects.
    - HIV clinical staging up to 30 days after the last dose of vaccine in HIV+ subjects.
    - HPV-16 and HPV-18 antibody titers by Pseudovirion-Based Neutralization Assay (PBNA) 30 days after the last dose of vaccine in HIV+ subjects.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Solicited symptoms: 7-day follow-up period after each and any vaccination.
    Unsolicited symptoms: 30-days follow-up period after any vaccination.
    SAEs, medically significant conditions, occurrence and outcome of pregnancies, clinically relevant abnormalities, CD4 cell count, HIV viral load, HIV clinical staging: Throughout the active phase of the study
    HPV-016 and HPV-018 antibody titers by Psuedovirion-Based Neutralisation Assay 30 days after last done: At month 7.
    E.5.2Secondary end point(s)
    - Occurrence and intensity of solicited local symptoms in HIV- subjects.
    - Occurrence, intensity and relationship to vaccination of solicited general symptoms in HIV - subjects.
    - Occurrence, intensity and relationship to vaccination of unsolicited symptoms in HIV- subjects.
    - Occurrence of SAEs up to 30 days after the last dose of vaccine in HIV- subjects.
    - Occurrence of medically significant conditions (including pIMDs) up to 30 days after the last dose of vaccine in HIV- subjects.
    - Occurrence and outcome of pregnancies in all subjects.
    - Occurrence of clinically relevant abnormalities in hematological and biochemical parameters in all subjects.
    - Occurrence of SAEs in all subjects.
    - Occurrence of medically significant conditions in all subjects.
    - CD4 cell count, HIV viral load and HIV clinical staging in HIV+ subjects.
    Immunogenicity:
    - HPV-16 and HPV-18 antibody titers by PBNA in HIV- subjects.
    - HPV-16 and HPV-18 antibody titers and total IgG titers by ELISA in serum in all subjects.
    - HPV-16 and HPV-18 antibody titers and total IgG titers by ELISA in CVS in post-menarcheal subjects who volunteer for this procedure.
    - Frequencies of HPV-16 and HPV-18 specific B cells and T cells in a subset of 100 subjects (50 HIV+ and 50 HIV-).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sol. symp: 7-day follow-up period after each, any vacc
    Unsol. symp: 30-days follow-up period after any vacc
    SAEs, medically significant conditions: Throughout the active phase of the study
    pregnancies occurrence,outcome: Upto M24
    clinically relevant abnormalities: M12,M18,M24
    SAE and medically significant conditions in all subjects: upto M24 and M12 respectively
    CD4 cell count, HIV viral load, clinical staging: At M 12,M18,M24
    HPV-016, HPV-018 antibody titers by PBNA: At month 7
    HPV-016, HPV-018 antibody titers, total IgG by ELISA in serum, in CVS of post-menarchal subjects: At Day 0, W6,W10, M7,M12, M18 (except for post menarchal subjects), M24
    Frequency of B and T cells: At Day 0, W6,W10, M7,M12
    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
    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 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
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    Brazil
    Estonia
    India
    Thailand
    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
    Last Visit Last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 250
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 250
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    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.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 700
    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)
    For their underlying condition, the subjects will continue to receive standard care, as provided by their physician.
    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 Decision2014-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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