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    Summary
    EudraCT Number:2009-014493-18
    Sponsor's Protocol Code Number:B1971012(6108A1-2003-EU)
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-014493-18
    A.3Full title of the trial
    A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged more or equal 11 to <19 Years
    Estudio en fase 2, aleatorizado, controlado con Placebo y simple ciego para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de la vacuna rLP2086 cuando se administra en pautas de 2 ó 3 dosis a sujetos sanos de edad superior o igual 11 a < 19 años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to determine if the investigational MnB vaccine works when 2 or 3 doses of the vaccine is given to adolescents.
    Ensayo Clínico para determinar si la vacuna MnB funciona al administrar 2 o 3 dosis de vacuna en adolescentes.
    A.4.1Sponsor's protocol code numberB1971012(6108A1-2003-EU)
    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 SponsorPFIZER S.L.U.
    B.1.3.4CountrySpain
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.5Fax number13037391119
    B.5.6E-mailClinicalTrials.govCallCentre@Pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMnB rLP2086
    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 INNMnB rLP2086 subfamilia A
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMnB rLP2086 subfamilia B
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (prevention of bacterial meningitis).
    Voluntarios sanos (prevención de meningitis bacteriana)
    E.1.1.1Medical condition in easily understood language
    Prevention of Meningitis caused by N.Meningitidis B bacteria.
    Prevención de Meningitis causada por la bacteria de N.Meningitidis B
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10027202
    E.1.2Term Meningitis bacterial
    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 as measured by serum bactericidal assay performed with
    MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the
    third vaccination with rLP2086 vaccine, administered according to a 0- 1- and 6-month
    schedule (group 1).
    - To assess the immune response as measured by serum bactericidal assay performed with
    MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the
    third vaccination with rLP2086 vaccine, administered according to a 0- 2- and 6-month
    schedule (group 2).
    -Evaluar la respuesta inmunitaria, determinada mediante el análisis de la actividad bactericida del suero realizado con cepas de MnB que expresan proteínas LP2086 de las subfamilias A y B, un mes después de la tercera dosis de la vacuna rLP2086 administrada según el calendario de 0, 1 y 6 meses (grupo 1).

    -Evaluar la respuesta inmunitaria, determinada mediante el análisis de la actividad bactericida del suero realizado con cepas de MnB que expresan proteínas LP2086 de las subfamilias A y B, un mes después de la tercera dosis de la vacuna rLP2086 administrada según el calendario de 0, 2 y 6 meses (grupo 2).
    E.2.2Secondary objectives of the trial
    - To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the second vaccination with rLP2086 vaccine, administered according to a 0-, , and 6-month schedule (group 3).
    - To describe the immune response as measured by serum bactericidal assay performed
    with MnB strains expressing LP2086 subfamily A and B proteins, throughout the study
    (all groups).
    - Evaluar la respuesta inmunitaria, determinada mediante el análisis de la actividad bactericida del suero realizado con cepas de MnB que expresan proteínas LP2086 de las subfamilias A y B, un mes después de la segunda dosis de la vacuna rLP2086 administrada según el calendario de 0 y 6 meses (grupo 3).

    - Describir la respuesta inmunitaria, determinada mediante el análisis de la actividad bactericida del suero realizado con cepas de MnB que expresan proteínas LP2086 de las subfamilias A y B, a lo largo del estudio (todos los grupos).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member
    of the investigator’s study team before subjects are included in the study.
    1. Evidence of a personally signed and dated informed consent document indicating that
    the parent/legally acceptable representative and/or subject has been informed of all
    pertinent aspects of the study.
    2. Parent/legally acceptable representative and/or subjects who are willing and able to
    comply with scheduled visits, treatment plan, laboratory tests, and other study
    procedures.
    3. Male or female subject aged ≥11 and <19 years at the time of enrollment.
    4. Available for the entire study period and can be reached by telephone.
    5. Healthy subject as determined by medical history, physical examination, and
    judgment of the investigator.
    6. All male and female subjects must agree to practice a form of effective contraception,
    such as barrier contraception (ie, condom plus spermicide, a female condom,
    diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral
    contraceptives or sexual abstinence prior to entering into the study, for the duration of
    the vaccination period and for 28 days after the last study vaccination. For
    Germany: The phrase sexual abstinence is not applicable, with the understanding that
    all male and all female subjects of childbearing potential must practice an effective
    form of contraception during the study.
    7. Negative urine pregnancy test for female subjects.
    Un miembro debidamente cualificado del equipo del estudio del investigador analizará y documentará la elegibilidad de los sujetos antes de su inclusión en el estudio.
    1. Existencia de un documento de consentimiento informado, firmado y fechado personalmente, en el que se indique que se ha informado al padre o representante legal y al sujeto de todos los aspectos pertinentes del estudio.
    2. El padre o representante legaly el sujeto están dispuestos a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio y son capaces de hacerlo.
    3. Sujetos de ambos sexos de 11 y < 19 años de edad en el momento de la inclusión.
    4. Sujetos disponibles durante todo el período de estudio a los que pueda localizarse por teléfono.
    5. Sujetos sanos a juzgar por la anamnesis, la exploración física y el criterio del investigador.
    6. Todos los sujetos, chicos y chicas, deben aceptar utilizar un método anticonceptivo eficaz, como anticonceptivos de barrera (preservativo más espermicida, preservativo femenino, diafragma, capuchón cervical o dispositivo intrauterino), implantes hormonales, anticonceptivos inyectables o combinados orales o abstinencia sexual, antes de la inclusión en el estudio, durante todo el período de vacunación y hasta 28 días después de la última vacunación del estudio.
    Para Alemania: no se incluirá la expresión abstinencia sexual, siempre y cuando todos los chicos y chicas en edad fértil utilicen un método anticonceptivo eficaz durante el estudio.
    7. Resultado negativo en la prueba de embarazo en orina en chicas
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Previous vaccination with any meningococcal serogroup B vaccine.
    2. A previous anaphylactic reaction to any vaccine or vaccine-related component
    3. Bleeding diathesis or condition associated with prolonged bleeding time that would
    contraindicate intramuscular injection.
    4. A known or suspected disease of the immune system or those receiving
    immunosuppressive therapy.
    5. History of culture-proven disease caused by Neisseria meningitidis or Neisseria
    gonorrhoeae.
    6. Significant neurological disorder or history of seizure (excluding simple febrile
    seizure).
    7. Receipt of any blood products, including immunoglobulin within 6 months before the
    first study vaccination.
    8. Current chronic use of systemic antibiotics.
    9. Participation in other studies during study participation. Participation in purely
    observational studies is acceptable.
    10. Received any investigational drugs, vaccines or devices within 28 days before
    administration of the first study vaccination.
    11. Any neuroinflammatory or autoimmune condition, including, but not limited to,
    transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
    12. Other severe acute or chronic medical or psychiatric condition or laboratory
    abnormality that may increase the risk associated with study participation or
    investigational product administration or may interfere with the interpretation of
    study results and, in the judgment of the investigator, would make the subject
    inappropriate for entry into this study.
    13. Subjects who are investigational site staff members or subjects who are Pfizer
    employees directly involved in the conduct of the trial.
    14. Subject is a direct descendant (e.g., child, grandchild or other family member) of study site or Pfizer personnel.
    15. Subject is pregnant or breastfeeding.
    No podrán participar en el estudio los sujetos que se encuentren en cualquiera de las circunstancias siguientes:
    1. Vacunación previa con cualquier vacuna frente a los meningococos del serogrupo B.
    2. Antecedentes de reacción anafiláctica a alguna vacuna o componente relacionado con la vacuna.
    3. Diátesis hemorrágica o procesos asociados a una prolongación del tiempo de hemorragia que contraindica una inyección intramuscular.
    4. Certeza o sospecha de enfermedad del sistema inmunitario y sujetos en tratamiento con inmunodepresores.
    5. Antecedentes de enfermedad por Neisseria meningitidis o Neisseria gonorrhoeae confirmada mediante cultivo.
    6. Enfermedad neurológica importante o antecedentes de crisis (salvo las crisis febriles simples).
    7. Recepción de hemoderivados, incluidas inmunoglobulinas, en los seis meses previos a la primera vacunación del estudio.
    8. Tratamiento crónico actual con antibióticos sistémicos.
    9. Participación en cualquier otro estudio mientras dure éste. Se aceptará la participación en estudios meramente observacionales.
    10. Tratamiento con cualquier fármaco, vacuna o dispositivo en investigación durante los 28 días previos a la primera vacunación del estudio.
    11. Cualquier enfermedad neuroinflamatoria o autoinmunitaria, como mielitis transversa, uveítis, neuritis óptica y esclerosis múltiple, entre otras.
    12. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía analítica que aumente el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interfiera en la interpretación de los resultados del estudio y, en opinión del investigador, impida la participación en el mismo.
    13. Sujetos que sean miembros del personal del equipo investigador o empleados de Pfizer directamente implicados en la realización del ensayo.
    14. Sujetos que sean descendientes directos (p.ej. hijos, nietos u otros miembros de la familia) del personal del centro o de Pfizer.
    15. Adolescentes embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the co-primary objectives are the proportion of sujects achieving an rLP2086-specific SBA titer > or = to 1:4, for each of the 4 primary strains, measured 1 month after the third vaccination with rLP2086 vaccine (or measured at month 7) (in groups 1 an 2, respectively)
    El criterio de valoración principal para los objetivos principales son la proporción de sujetos que logran un título de ABS específica para la rLP2086 mayor o igual a 1:4 con cada una de las cuatro cepas principales, medido un mes después de la tercera dosis de la vacuna rLP2086 (o en el mes 7) (en los grupos 1 y 2, respectivamente).
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after the third dose of rLP2086 (Groups 1 and 2).
    Un mes después de la tercera dosis de rLP2086 (Grupos 1 y 2).
    E.5.2Secondary end point(s)
    The endpoint for the first of the secondary objectives is the proportion of subjects achieving an rLP2086-specific SBA titer ≥1:4 for each of the 4 primary strains, measured 1 month after the second vaccination with rLP2086 vaccine (or measured at month 7) in group 3.
    The testing strategy for the above hypothesis testing endpoints is described in Section 11.5.
    Additional secondary endpoints for descriptive purposes include the following:
    1.SBA titers for each of the 4 primary strains at each blood sampling time point;
    2.Proportion of subjects achieving an rLP2086-specific SBA titer ≥1:4, for each of the 4 primary strains, at each blood sampling time point;
    3.Proportion of subjects achieving a 4-fold rise on rLP2086-specific SBA titer from baseline (day 1) to each blood sampling time point;
    4.Proportions of subjects achieving rLP2086-specific SBA titers ≥1:8 at each blood sampling time point;
    5.Proportions of subjects achieving rLP2086-specific SBA titers ≥1:16 at each blood sampling time point;
    6.Proportions of subjects achieving rLP2086-specific SBA titers ≥1:32 at each blood sampling time point;
    7.Proportions of subjects achieving rLP2086-specific SBA titers ≥1:64 at each blood sampling time point;
    8.Proportions of subjects achieving rLP2086-specific SBA titers ≥1:128 at each blood sampling time point;
    9.Fold-rise for the following:
    •Fold-rise from baseline to month 7;
    •Fold-rise from baseline to month 3;
    •Fold-rise from baseline to month 2.
    El criterio de valoración para el primero de los objetivos secundarios es la proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:4 con cada una de las cuatro cepas principales, medido un mes después de la segunda dosis de la vacuna rLP2086 (o en el mes 7) en el grupo 2.
    En la sección 11.5 se describe la estrategia de verificación de los criterios de valoración de la hipótesis anterior.
    Otros criterios de valoración secundarios con fines descriptivos serán los siguientes:
    1. Títulos de ABS para cada una de las cuatro cepas principales en cada punto temporal de extracción de sangre;
    2. Proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:4 con cada una de las cuatro cepas principales en cada punto temporal de extracción de sangre;
    3. Proporción de sujetos que alcanzan un aumento de 4 veces en el título de la ABS específica para la rLP2086 con respecto al valor basal (día 1) en cada punto temporal de extracción de sangre;
    4. Proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:8 en cada punto temporal de extracción de sangre;
    5. Proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:16 en cada punto temporal de extracción de sangre;
    6. Proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:32 en cada punto temporal de extracción de sangre;
    7. Proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:64 en cada punto temporal de extracción de sangre;
    8. Proporción de sujetos que logran un título de ABS específica para la rLP2086 ≥ 1:128 en cada punto temporal de extracción de sangre;
    9. Aumento en número de veces en lo siguiente:
    • Aumento en número de veces en el mes 7
    • Aumento en número de veces en el mes 3
    • Aumento en número de veces en el mes 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    One month after the second dose of rLP2086 (group 3) and at other time points detailed in E.5.2.
    Un mes tras la segunda dosis de rLP2086 (Grupo 3) y en otros criterios de valoración detallados en la sección E.5.2.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    As per protocol
    Según protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 1524
    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: 190
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1334
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 190
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-06-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Población adolescente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1714
    F.4.2.2In the whole clinical trial 1714
    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)
    Los pacientes volverán al seguimiento habitual una vez que su participación en el estudio haya terminado.
    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 Decision2010-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-18
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