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    Summary
    EudraCT Number:2012-001876-13
    Sponsor's Protocol Code Number:113823
    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:2012-09-25
    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 number2012-001876-13
    A.3Full title of the trial
    A Phase III, open, randomized, controlled, multicenter study to assess the immunogenicity and reactogenicity of GSK Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered alone as compared to MenACWY-TT co-administered with a licensed viral vaccine or co-administered with a licensed viral vaccine and GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) (Boostrix) in female adolescents and young adults at 9-25 years of age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ meningococcal vaccine with or without co-administration of a licensed viral vaccine and Boostrix in female adolescents and young adults.
    A.3.2Name or abbreviated title of the trial where available
    MenACWY-TT-054
    A.4.1Sponsor's protocol code number113823
    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'Insitut, 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 Nimenrix
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenA-TT
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenC-TT
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenW-TT
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenY-TT
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name 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.3.1Product nameCervarix
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22594
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22593
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 3
    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 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 INNPurified diphtheria toxoid
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive namePurified diphtheria toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit LfU lime flocculation unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPurified tetanus toxoid
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive namePurified tetanus toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit LfU lime flocculation unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPurified Pertussis toxoid
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePurified Pertussis toxoid
    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 INNPurified filamentous Haemagglutin
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive namePurified filamentous Haemagglutin
    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 INNPurified Pertactin
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePurified Pertactin
    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
    Meningococcal disease
    E.1.1.1Medical condition in easily understood language
    Inflammation of the brain and infection of the blood
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10028911
    E.1.2Term Neisseria meningitidis infection NOS
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10032810
    E.1.2Term Other specified meningococcal infections
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10070124
    E.1.2Term Neisseria meningitidis test positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To demonstrate non-inferiority of MenACWY-TT co-ad with a viral vaccine compared to MenACWY-TT alone with respect to GMTs for A, C, W-135 and Y.
    •To demonstrate the non-inferiority of a viral vaccine co-ad with MenACWY-TT compared to a viral vaccine alone in terms of HPV GMTs.
    •To demonstrate non-inferiority of MenACWY-TT co-ad with a viral vaccine and Boostrix compared to MenACWY-TT alone with respect to GMTs for A, C, W-135 and Y.
    •To demonstrate non-inferiority of a viral vaccine co-ad with MenACWY-TT and Boostrix compared to a viral vaccine co-administered with Boostrix in terms of HPV GMTs.
    •To demonstrate non-inferiority of Boostrix co-ad with MenACWY-TT and a viral vaccine compared to Boostrix co-administered with a viral vaccine in terms of anti-D and anti-T concentrations.
    •To demonstrate non-inferiority of Boostrix co-ad with MenACWY-TT and a viral vaccine compared to Boostrix co-administered with a viral vaccine with respect to GMCs to pertussis antigens.
    E.2.2Secondary objectives of the trial
    immunogenicity of subjects in the ACWYHPV, ACWY-TT and Co-ad groups in terms of subjects with rSBA titres and vaccine response.
    immunogenicity of the TT carrier protein in the ACWY-TT group in terms of subjects with anti-T concentrations and GMCs.
    immunogenicity of a viral vaccine in subjects in the ACWYHPV, HPV, Co-ad, ACWY-TT and Tdap groups with respect to subjects with titres ≥8 EL.U/mL for anti-HPV16 and ≥7 EL.U/mL for anti-HPV18.
    immunogenicity of subjects in the ACWY-TT group with respect to HPV16 and HPV18 GMTs.
    immunogenicity of all subjects with respect to seroconversion rates of anti-HPV titers.
    the booster responses to PT, FHA and PRN in the Co-ad and Tdap groups.
    the immunogenicity of Boostrix in the Co-ad and Tdap groups in terms of anti-D and anti-T concentrations and GMCs, and anti-PT, FHA and PRN concentrations.
    Solicited local and general symptoms
    ­Unsolicited adverse events.
    SAEs and NOCI(s) and pIMDs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects and subjects’ 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.

    A female between, and including, 9 and 25 years of age at the time of the first vaccination.

    Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than legal age, or written informed consent obtained from the subject if the subject has achieved legal age. The legal age will be determined according to local regulations in each participating country.

    Healthy subjects as established by medical history and clinical examination before entering into the study.

    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 for 30 days prior to vaccination, and
    -has a negative pregnancy test on the day of vaccination, and
    -has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
    E.4Principal exclusion criteria
    Child in care

    Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will be ≥10 mg/day prednisone or equivalent. Inhaled and topical steroids are allowed.

    Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after each study dose of vaccine(s), with the exception of licensed inactivated influenza vaccine.

    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 product or a non-investigational vaccine/product.

    Previous vaccination with a meningococcal polysaccharide or conjugate vaccine within the last 10 years.

    History of meningococcal disease since birth.

    History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.

    History of encephalopathy within seven days of administration of a previous pertussis antigen-containing vaccine that is not attributable to another identifiable cause.

    Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus-toxoid containing vaccine should not receive Boostrix unless at least 10 years have elapsed since the last dose of tetanus-toxoid containing vaccine.

    Previous vaccination with a tetanus-toxoid containing vaccine within the previous five years.

    Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine (diphtheria-tetanus-whole cell pertussis [DTPw] and/or diphtheria-tetanus-acellular pertussis [DTaP]), not due to another identifiable cause.

    Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.

    Seizures with or without fever within three days of a previous dose of DTP vaccine.

    Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and history directed physical examination.

    A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

    History of any allergic disease/reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).

    Progressive neurologic disorder, unstable neurologic conditions, uncontrolled epilepsy or progressive encephalopathy.

    History of any neurologic disorders or seizures. A history of ADHD or depression or a history of a single, simple febrile seizure does not exclude a subject.

    Major congenital defects or serious chronic illness.

    Previous history of Guillain-Barré Syndrome.

    Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.

    Acute disease and/or fever at the time of enrolment.

    Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

    Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.

    Previous administration of MPL or AS04 adjuvant.

    History of chronic alcohol consumption and/or drug abuse.

    Pregnant or lactating female.

    A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.

    Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
    E.5 End points
    E.5.1Primary end point(s)
    rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY GMTs in the ACWY-TT, ACWYHPV and Co-ad groups.

    Anti-HPV16 and anti-HPV18 GMTs in the HPV, ACWYHPV, Co-ad and Tdap groups.

    anti-D and anti-T concentrations ≥1.0 IU/mL in the Co-ad and Tdap groups
    anti-PT, anti-FHA and anti-PRN GMCs in the Co-ad and Tdap groups


    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after vaccination with MenACWY-TT.

    One month after the 3rd dose of a licensed viral vaccine.

    One month after vaccination with Boostrix.



    E.5.2Secondary end point(s)
    rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titres ≥1:8, ≥1:128 and vaccine response one month post-vaccination in all subjects of the ACWYHPV, ACWY-TT and Co-ad groups.

    Anti-T concentrations ≥0.1 IU/mL, ≥1.0 IU/mL and GMCs in the ACWY-TT group.

    •Anti-HPV16 titres ≥8 EL.U/mL and anti-HPV18 titres ≥7 EL.U/mL in the ACWYHPV, HPV, Co-ad, ACWY-TT and Tdap groups.
    •Anti-HPV16 and anti-HPV18 seroconversion rates in the ACWYHPV, ACWY-TT, HPV, Co-ad and Tdap groups post-dose 3.
    •Anti-HPV16 and anti-HPV18 GMTs in the ACWY-TT group.

    •Booster responses for PT, FHA and PRN in the Co-ad and Tdap groups
    •Anti-D and anti-T concentrations ≥0.1 IU/mL and GMCs in the Co-ad and Tdap groups
    •Anti-PT, anti-FHA and anti-PRN concentrations ≥5 EL.U/mL in the Co-ad and Tdap groups

    Occurrence of solicited local and general symptoms after vaccination with MenACWY-TT in the ACWYHPV, ACWY-TT and Co-ad groups, after the first dose of a licensed viral vaccine in the ACWY-TT, HPV and Tdap groups and after vaccination with Boostrix in the Co-ad and Tdap groups.

    Occurrence of unsolicited adverse events after vaccination with MenACWY-TT, Boostrix or the first dose of a licensed viral vaccine in all groups according to the Medical Dictionary for Regulatory Activities (MedDRA).

    Occurrence of serious adverse events in all groups after the first vaccination.

    New onset of chronic illness(es) (NOCIs) (e.g., autoimmune disorders, asthma, type I diabetes and allergies) and pIMDs in all groups.








    E.5.2.1Timepoint(s) of evaluation of this end point
    Prior to and one month after vaccination with MenACWY-TT.

    Prior to and one month after vaccination with MenACWY-TT.

    Prior to the first dose of a licensed viral vaccine and one month after the 3rd dose of a licensed viral vaccine.

    Prior to and one month after vaccination with Boostrix

    During Days 0-6 following vaccination with MenACWY-TT, Boostrix or the first dose of a licensed viral vaccine.

    During Days 0-30 following vaccination with MenACWY-TT, Boostrix or the first dose of a licensed viral vaccine.

    Up to 8 months after the first vaccination.

    Up to 8 months after the first 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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 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
    Brazil
    Dominican Republic
    Thailand
    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
    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 months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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: 1300
    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: 325
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 650
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 325
    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 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.4.1In the member state435
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 435
    F.4.2.2In the whole clinical trial 1300
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-29
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