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    Summary
    EudraCT Number:2014-001117-41
    Sponsor's Protocol Code Number:201330
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001117-41
    A.3Full title of the trial
    A phase IV, open‐label, non‐randomised, multi‐centre study to assess the immunogenicity and safety of Infanrix hexa™ administered as primary
    vaccination in healthy infants born to mothers given Boostrix™ during pregnancy or post‐delivery in 116945 [DTPA (BOOSTRIX)‐047].
    Studio multicentrico di fase IV in aperto non randomizzato atto a valutare l’immunogenicità e la sicurezza di Infanrix hexa® quando è somministrato come vaccinazione primaria in lattanti nati sani da madri vaccinate con Boostrix® durante la gravidanza oppure in post‐partum nello studio 116945 [DTPA (BOOSTRIX)‐047]. Studio multicentrico di fase IV in aperto non randomizzato atto a valutare l’immunogenicità e la sicurezza di Infanrix hexa® quando è somministrato come vaccinazione primaria in lattanti nati sani da madri
    vaccinate con Boostrix® durante la gravidanza oppure in post‐partum nello studio 116945 [DTPA (BOOSTRIX)‐047].
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery.
    Studio atto a valutare l’immunogenicità e la sicurezza di Infanrix hexa® in lattanti nati sani da madri vaccinate con Boostrix® durante la gravidanza oppure in post‐partum.
    A.3.2Name or abbreviated title of the trial where available
    DTPA (BOOSTRIX)-048 PRI
    DTPA (BOOSTRIX)-048 PRI
    A.4.1Sponsor's protocol code number201330
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGLAXOSMITHKLINE BIOLOGICALS
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de I'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number00442089904466
    B.5.5Fax number0
    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 INFANRIX HEXA - POLVERE E SOSPENSIONE PER SOSPENSIONE INIETTABILE 1 FLACONCINO + 1 SIRINGA PRERIEMPITA 0.5 ML USO INTRAMUSCOLARE
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE BIOLOGICALS S.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    D.3.9.4EV Substance CodeSUB14817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive nameFILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB38509
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePERTUSSIS PERTACTIN
    D.3.9.4EV Substance CodeSUB20527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 PREVENAR 13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB30925
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB30926
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25336
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB30927
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB30928
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Healthy volunteers [Primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)].
    Volontari sani [Immunizzazione primaria del lattante contro difterite, tetano, pertosse, epatite B, poliomielite e malattia da Haemophilus influenzae di tipo b (Hib)]
    E.1.1.1Medical condition in easily understood language
    Diphtheria, Lock jaw, Whopping cough, Hepatitis B
    Polio, Influenza
    Difterite, tetano, pertosse, pertosse, epatite B, poliomielite, influenza
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10006025
    E.1.2Term Bordetella pertussis laryngotracheobronchitis
    E.1.2System Organ Class 100000004862
    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 immunological response to DTPa-HBV-IPV/Hib in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and
    Hib antigens, and in terms of vaccine response to the pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
    Valutare la risposta immunologica a Infanrix hexa in termini di stato di sieroprotezione per gli
    antigeni di difterite, tetano, epatite B, poliovirus e Hib e in termini di risposta vaccinale agli
    antigeni della pertosse un mese dopo la somministrazione dell’ultima dose di vaccinazione
    primaria nei lattanti nati da madri vaccinate con Boostrix durante la gravidanza o
    nell’immediato post‐partum.
    E.2.2Secondary objectives of the trial
    •To assess persistence of antibodies against diphtheria, tetanus and pertussis antigens, before the first dose of DTPa-HBV-IPV/Hib in infants
    born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery. •To assess the immunological response to DTPa-HBV-IPV/Hib and 13Pn
    in terms of antibody concentrations or titres against all antigens, one month* after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately postdelivery. •To assess the immunological response to DTPa-HBV-IPV/Hib in terms of seropositivity rates against pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers
    vaccinated with Boostrix during pregnancy or immediately post-delivery. •To assess the safety and reactogenicity of DTPa-HBV-IPV/Hib and 13Pn
    in terms of solicited and unsolicited symptoms and serious adverse events (SAEs).
    Valutare la persistenza degli anticorpi per gli antigeni di difterite,tetano e pertosse prima della somm della 1°dose di Infanrix hexa nei lattanti nati da madri vaccinate con Boostrix durante la gravidanza o nell’immediato post‐partum;Valutare la risposta immunologica a Infanrix hexa e a Prevenar13 in termini di concentrazioni o titoli anticorpali contro tutti gli antigeni un mese* dopo la somm dell’ultima dose di vaccinazione primaria nei lattanti nati da madri vaccinate con Boostrix durante la gravidanza o nell’immediato post‐partum.*In alcuni paesi/regioni in cui è previsto uno schema vaccinale a 3dosi per Infanrix hexa,Prevenar13 potrebbe essere somm con uno schema di vaccinazione primaria a 2 o 3 dosi. In tal caso, la valutazione sarà eseguita un mese dopo la somm dell’ultima dose di Infanrix hexa indipendentemente dalla vaccinazione con Prevenar13.Nei paesi/regioni in cui è previsto uno schema a 2 dosi per Infanrix hexa, Prevenar13 sarà co‐somm contestualmente a Infanrix hexa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •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 (e.g. completion of the diary cards, return for follow-up visits).
    •Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
    •A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the
    first vaccinationat the time of the first vaccination.
    •Healthy subjects as established by medical history and clinical examination before entering into the study.
    •Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
    •Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of
    the investigator. *Medically stable refers to the condition of premature infants who do not
    require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.
    - Avere un genitore o un rappresentante legalmente riconosciuto [LAR] che, a giudizio dello sperimentatore, abbia la capacità e l’intenzione di soddisfare i requisiti fissati dal protocollo (ad
    es. compilazione delle schede diario, disponibilità a effettuare visite di follow‐up).
    - Consenso informato scritto da parte del genitore/LAR, rilasciato prima della conduzione di una qualsiasi procedura specifica per lo studio.
    - Soggetti di sesso femminile o maschile di età compresa tra le 6 e le 14 settimane d’età (inclusa
    l’età di 6 settimane e fino a 14 settimane e 6 giorni compiuti) al momento della prima vaccinazione.
    - Soggetti sani sulla base dell’anamnesi medica e dell’esame clinico prima dell’accesso allo studio.
    - Bambini nati da madri arruolate nello studio 116945 [DTPA (BOOSTRIX)‐047].
    - I prematuri con un quadro medico stabile* nati dopo una gestazione di 27‐36 settimane possono
    essere arruolati nello studio a discrezione del giudizio del medico sperimentatore.
    *Per “quadro medico stabile” si intende che il prematuro non necessita di un supporto medico
    significativo o di un trattamento attuale per malattia debilitante e ha dimostrato un decorso
    clinico di recupero continuo al momento in cui riceverà la prima dose del vaccino in studio.
    E.4Principal exclusion criteria
    •Child in care
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean predni-sone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
    •Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
    •Administration of any chronic drug therapy to be continued during the study period.
    •A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30
    days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation
    schedule, that are allowed at any time during the study period. *In case an emergency mass vaccination for an unforeseen public health
    threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or package insert (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
    •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
    •Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
    •History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID),
    based on medical history and physical examination (no laboratory testing required).
    •Family history of congenital or hereditary immunodeficiency.
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    •Major congenital defects
    •Serious chronic illness.
    •History of any neurological disorders or seizures.
    •Acute disease and/or fever at the time of enrolment.
    - Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
    - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of
    the investigator.
    •Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or
    planned administration during the study period.
    •Hypersensitivity to latex.
    - Bambino/a sottoposto/a a custodia;- Somministrazione cronica (intesa come somministrazione di durata >14 giorni in totale) di immunosoppressori o altri farmaci immuno‐modulanti durante il periodo che va dalla nascita al momento antecedente la somministrazione della prima dose di vaccino. Per quanto riguarda i corticosteroidi, ciò corrisponde a una dose di prednisone ≥0,5 mg/kg/die o equivalente. È consentito l’uso di steroidi per via topica e inalatoria;- Somministrazione di farmaci immuno‐modulanti a lunga durata d’azione in qualsiasi momento durante lo svolgimento dello studio (ad es. infliximab);- Somministrazione di terapie farmacologiche croniche da proseguirsi durante lo svolgimento dello studio;- Somministrazione di un vaccino non previsto dal protocollo sperimentale durante il periodo compreso tra i 30 giorni precedenti la somministrazione di ciascuna dose di vaccino e i 30 giorni successivi*, fatta eccezione per il vaccino antinfluenzale inattivato e altri vaccini somministrati nel contesto del piano nazionale/regionale di prevenzione vaccinale, la cui somministrazione è ammessa in qualsiasi momento dello studio.*Qualora le autorità sanitarie pubbliche prevedano un programma di vaccinazione di massa di emergenza giustificata da un problema di sanità pubblica imprevisto (ad es. una pandemia) al di fuori del programma di prevenzione vaccinale di routine, il periodo sopraindicato potrà essere ridotto laddove necessario per il vaccino in questione, a condizione che si tratti di un prodotto autorizzato e usato conformemente al relativo RCP o foglio illustrativo e nel rispetto delle raccomandazioni governative locali ed a condizione che lo sponsor abbia rilasciato un’approvazione scritta;- Contemporanea partecipazione ad un altro studio clinico – in qualsiasi momento durante lo svolgimento dello studio – in cui il soggetto sia stato o sarà esposto a un vaccino/prodotto sperimentale o non sperimentale (dispositivo o prodotto farmaceutico);- Vaccinazione pregressa contro Hib, difterite, tetano, pertosse, malattia pneumococcica e/o poliomielite dopo la nascita;- Anamnesi positiva per malattia da Hib, difterite, tetano, pertosse, malattia pneumococcica, infezione da poliovirus ed epatite B;- Qualsiasi condizione di immunosoppressione o immunodeficienza confermata o sospetta, inclusa immunodeficienza combinata grave (SCID), sulla base dell’anamnesi medica e dell’esame obiettivo (test di laboratorio non necessari);- Anamnesi familiare positiva per immunodeficienza congenita o ereditaria;- Anamnesi positiva per una qualunque reazione o ipersensibilità che potrebbe essere esacerbata da un qualsiasi componente del vaccino;- Difetti congeniti maggiori;- Malattia cronica grave;- Anamnesi positiva per disturbi neurologici o crisi convulsive;- Malattia acuta e/o febbre al momento dell’arruolamento;- La febbre è intesa come una temperatura corporea ≥ 37,5 °C misurata per via orale,
    ascellare o timpanica, oppure ≥ 38,0 °C per via rettale; - I soggetti apiretici con una malattia minore (ad es. diarrea lieve, lieve infezione delle alte vie aeree) possono essere arruolati a discrezione del giudizio del medico sperimentatore;- Somministrazione di immunoglobuline e/o qualunque prodotto ematico nel periodo compreso tra la nascita e il momento antecedente alla somministrazione della prima dose dei vaccini sperimentali, o somministrazione programmata durante lo svolgimento dello studio;- Ipersensibilità al lattice.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to components of DTPa-HBV-IPV/Hib.
    - Anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, antipoliovirus type 2, anti-poliovirus type 3 and anti-polyribosyl-ribitol
    phosphate (anti-PRP) seroprotection status.
    - Vaccine response to PT, FHA and PRN antigens.
    Immunogenicità relativamente ai componenti di Infanrix hexa.
    - Stato di sieroprotezione antidifterica, antitetanica, anti‐HB, anti‐poliovirus di tipo 1, anti‐poliovirus di tipo 2, anti‐poliovirus di tipo 3 e anti‐poliribosilribitolfosfato (anti‐
    PRP), un mese dopo la somministrazione dell’ultima dose di vaccinazione primaria.
    - Risposta vaccinale agli antigeni PT, FHA e PRN un mese dopo la somministrazione
    dell’ultima dose di vaccinazione primaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 or Month 5 (depending on vaccination schedule of the country).
    Mese 3 o mese 5 (in base allo schema vaccinale previsto dal paese/regione)
    E.5.2Secondary end point(s)
    Occurrence of serious adverse events.
    Eventi avversi seri
    - Insorgenza di SAE nel periodo compreso tra la somministrazione della prima dose di
    vaccino e il termine dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Month 0 up to Month 3 or Month 5 (depending on vaccination schedule of the country).
    Durante il periodo compreso tra la somministrazione della prima dose di vaccino e il termine dello studio.
    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
    Immunogenicità
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Czech Republic
    Finland
    Italy
    Spain
    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 testing results released of samples collected at Visit 4.
    Ultimi risultati dei test relativi ai campioni raccolti in occasione della visita 4.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days21
    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: 1
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 680
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 680
    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
    Nessuno
    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 Decision2017-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
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