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    Summary
    EudraCT Number:2018-004581-34
    Sponsor's Protocol Code Number:FIHP201801
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-22
    Trial 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 number2018-004581-34
    A.3Full title of the trial
    An open-label Phase IV trial to evaluate the immunogenicity and safety of Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b (DTaP-IPV-HB-Hib) conjugate vaccine (adsorbed) in preterm infants
    Ensayo abierto de Fase IV para evaluar la inmunogenicidad y seguridad de la vacuna hexavalente difteria, tetanos, tos ferina (componente acelular) hepatitis B (rDNA), poliomyelitis (inactivada) y Haemophilus influenza tipo b (DTaP-IPV-HB –Hib) en lactantes prematuros
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the efficacy and safety la vacuna hexavalente (Hexyon) in preterm infants
    Evaluar la eficacia y seguridad de la vacuna hexavalente (Hexyon) en recién nacidos prematuros
    A.4.1Sponsor's protocol code numberFIHP201801
    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 SponsorFundación Instituto Hispalense de Pediatría
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSANOFI
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Instituto Hispalense de Pediatría
    B.5.2Functional name of contact pointDr. Ignacio Salamanca
    B.5.3 Address:
    B.5.3.1Street AddressC/ Jardín de la isla, nº 6. Edificio Expolocal
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41014
    B.5.3.4CountrySpain
    B.5.4Telephone number+349546100223
    B.5.5Fax number+34954690155
    B.5.6E-mailinvestigacion@ihppediatria.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 Hexyon®
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR EUROPE
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameHexyon
    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 INNHexyon
    D.3.9.3Other descriptive nameDIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACT.) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED)
    D.3.9.4EV Substance CodeSUB25314
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    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
    Vaccines, Bacterial and viral vaccines combined
    Vacunas, vacunas bacterianas y virales combinadas.
    E.1.1.1Medical condition in easily understood language
    Vaccines
    Vacunas
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Immunologic response of DTaP-IPV-HB-Hib vaccine (licensed in Spain as Hexyon®) (Sanofi Pasteur) vaccine in preterm infants.
    All antibody determinations will be performed at the Sanofi Pasteur Global Clinical Immunology (GCI) platform using qualified assays.
    Respuesta inmunológica de la vacuna DTaP-IPV-HB-Hib (autorizada en España como Hexyon®) (Sanofi Pasteur) en lactantes prematuros.
    Todas las determinaciones de anticuerpos se realizarán en la plataforma de Inmunología Clínica Global (GCI) de Sanofi Pasteur utilizando ensayos calificados.
    E.2.2Secondary objectives of the trial
    Reactogenicity and safety of Hexyon® vaccine in preterm infants.
    Reactogenicidad y seguridad de la vacuna Hexyon® en lactantes prematuros.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Preterm infants born between 24 (+0 days) – 36 (+6 days) weeks (42-90 days) (mean gestational age ± standard deviation, 31.05 ± 3.45 weeks) of gestation.
    • Subjects whose parents or legal guardians be able and wish to comply with all protocol requirements.
    - Male or female children 6 to 12 (42-90 days) weeks of age at first vaccine.
    - Written informed consent provided by the patient’s parents or legal guardians.
    - Healthy subjects according the investigator criteria prior to the enrolling in the trial.
    • Bebés prematuros nacidos entre las 24 (+0 días) - 36 (+6 días) semanas (42-90 días) (edad gestacional media ± desviación estándar, 31.05 ± 3.45 semanas) de gestación.
    • Sujetos cuyos padres o tutores legales pueden y desean cumplir con todos los requisitos del protocolo.
    - Niños varones o hembras de 6 a 12 (42-90 días) semanas de edad en la primera vacuna.
    - Consentimiento informado por escrito proporcionado por los padres o tutores legales del paciente.
    - Sujetos sanos según los criterios del investigador antes de la inscripción en el ensayo
    E.4Principal exclusion criteria
    • Foster children (male or female)
    • Receipt of any investigational product (drug or vaccine) within 30 days before the first dose of study vaccine or planned during the trial period.
    • Prolonged administration (defined as a total period of over 14 days) of immunosuppressive or other immunomodulatory drugs since the birth. In case of corticoids, this implies ≥ 0.5 mg/kg/day prednisone dose or equivalent. Inhaled or topic steroids will be allowed.

    • During the study period, simultaneous participation in another trial in which the subject have received or will be expected to receive investigational or non experimental product (pharmaceutical product or medical device).
    • Taking in account the clinical history and physical exam, any known or suspected status of immunosuppression or immunodeficiency.
    • Family history of congenital or inherited immunodeficiency.
    • History of reaction or hypersensibility probably exacerbated by any of the vaccine components.
    • Major congenital defects or serious chronic diseases, including Kawasaki syndrome.
    • History of severe neurologic damage or seizures, including both disorders and episodes of hypotension or hypo-responsiveness, encephalopathies or any type of convulsions (febrile and afebrile).
    • Episode of apnea (cessation of respiration > 20s) within 7 days before vaccination.
    • Acute disease and/or fever at recruitment in the study.
     Fever is defined as a temperature ≥ 37.5ºC (oral or axial temperature) or ≥ 38.0º C (rectal temperature).
     Subjects with mild diseases (such us mild diarrhea or mild upper respiratory tract infection) without fever could be recruited at physician discretion.
    • History of any immunoglobulin therapy and/or blood product since the birth or scheduled administration during the trial.
    • History of diphtheria, tetanus, pertussis, hepatitis B, polio and Hib vaccination or disease.
    • Any disease which in the opinion of the investigator would interfere with the evaluation of the objectives of the study.
    • Niños de acogida (hombres o mujeres)
    • Recepción de cualquier producto en investigación (medicamento o vacuna) dentro de los 30 días anteriores a la primera dosis de la vacuna del estudio o planificada durante el período de prueba.
    • Administración prolongada (definida como un período total de más de 14 días) de inmunosupresores u otros fármacos inmunomoduladores desde el nacimiento. En el caso de los corticoides, esto implica ≥ 0,5 mg / kg / día de dosis de prednisona o equivalente. Estarán permitidos los esteroides inhalados o tópicos.
    • • Durante el período de estudio, participación simultánea en otro ensayo en el que el sujeto ha recibido o se espera que reciba un producto en investigación o no experimental (producto farmacéutico o dispositivo médico).
    • Teniendo en cuenta la historia clínica y el examen físico, cualquier estado conocido o sospechado de inmunosupresión o inmunodeficiencia.
    • Antecedentes familiares de inmunodeficiencia congénita o hereditaria.
    • El historial de reacción o hipersensibilidad probablemente se exacerbe por alguno de los componentes de la vacuna.
    • Principales defectos congénitos o enfermedades crónicas graves, incluido el síndrome de Kawasaki.
    • Antecedentes de daño neurológico grave o convulsiones, que incluyen trastornos y episodios de hipotensión o hipo-respuesta, encefalopatías o cualquier tipo de convulsiones (febril y afebril).
    • Episodio de apnea (cese de la respiración> 20 s) dentro de los 7 días anteriores a la vacunación.
    • Enfermedad aguda y / o fiebre en el reclutamiento en el estudio.
    • La fiebre se define como una temperatura ≥ 37.5ºC (temperatura oral o axial) o ≥ 38.0º C (temperatura rectal).
    • Los sujetos con enfermedades leves (como diarrea leve o infección leve del tracto respiratorio superior) sin fiebre podrían ser reclutados a criterio del médico.
    • Historial de cualquier terapia de inmunoglobulina y / o producto sanguíneo desde el nacimiento o la administración programada durante el ensayo.
    • Historial de vacunación o enfermedad contra la difteria, el tétanos, la tos ferina, la hepatitis B, la poliomielitis y el Hib.
    • Cualquier enfermedad que, en opinión del investigador, interfiera con la evaluación de los objetivos del estudio.•
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of preterm infants who develop seroprotection/vaccine response (SP/VR) against all vaccine antigens 30 days after the second dose (month 5) and 30 days after the end of vaccination (month 12).

    Estimation of the confidence interval (95%) of the proportion of preterm infants who present immune response for the following antibodies 30 days after the second dose (month 5), the day of the third dose (month 11) and 30 days after the end of the vaccination (month 12)

    • Anti-diphteria- Diphteria toxoid antigen, D
    • Anti tetanus- Tetanus toxoid antigen, T
    • Anti-PT (target disease Pertussis)- pertussis toxoid antigen
    • Anti- FHA (target disease Pertussis)- filamentous hemagglutinin
    • Anti-polio virus
    o Type 1 (Mahoney) - D antigen of the poliovirus (PV) serotype 1
    o Type 2 (MEF-1)- D antigen of the poliovirus (PV) serotype 1
    o Type 3 (Saukett) - D antigen of the poliovirus (PV) serotype 1
    • Anti hepatitis B- Hepatitis B surface antigen, HBsAg
    • Anti-PRP (target disease, Invasive H. influenza disease)- polyribosylribitol phosphate
    Estimación del intervalo de confianza (95%) de la proporción de recién nacidos prematuros que presentan respuesta inmune para los siguientes anticuerpos 30 días después de la segunda dosis (mes 5), el día de la tercera dosis (mes 11) y 30 días después del final de la vacunación (mes 12)

    • Anti-difteria - antígeno toxoide diftérico, D
    • Antígeno antitetano-toxoide tetánico, T
    • Anti-PT (enfermedad de tos ferina) - antígeno toxoide de la tos ferina
    • Anti- FHA (enfermedad de tos ferina diana) - hemaglutinina filamentosa
    • Virus anti-polio
    o Tipo 1 (Mahoney): antígeno D del poliovirus (PV) serotipo 1
    o Tipo 2 (MEF-1): antígeno D del poliovirus (PV) serotipo 1
    o Tipo 3 (Saukett): antígeno D del poliovirus (PV) serotipo 1
    • Antihepatitis B: antígeno de superficie de la hepatitis B, HBsAg
    • Anti-PRP (enfermedad objetivo, enfermedad invasiva por influenza): fosfato de polirribosilribitol
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    • Reactogenicity of Hexyon® vaccine will be evaluated by measuring the proportion of subjects with:

    o Solicited adverse events (AEs) during a follow-up period of 8 days (days 0 to 7) after each vaccination.

    • Safety of Hexyon® vaccine will be evaluated by measuring the proportion of subjects with:

    o AEs spontaneously reported by the vaccines during a follow-up period of 31 days (days 0 to 30) after each vaccination.
    o Serious adverse events (SAEs) during the total study period
    • La reactogenicidad de la vacuna Hexyon® se evaluará midiendo la proporción de sujetos con:

    o Eventos adversos solicitados (EA) durante un período de seguimiento de 8 días (días 0 a 7) después de cada vacunación.

    • La seguridad de la vacuna Hexyon® se evaluará midiendo la proporción de sujetos con:

    o AE informadas espontáneamente por las vacunas durante un período de seguimiento de 31 días (días 0 a 30) después de cada vacunación.
    o Eventos adversos graves (EAG) durante el período total de estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 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 concerned5
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLP
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 140
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 140
    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) 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 No
    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 No
    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
    Preterm infants
    Lactantes pretérminos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    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
    NINGUNO
    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 Decision2019-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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