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    Summary
    EudraCT Number:2010-021491-28
    Sponsor's Protocol Code Number:V419-008
    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:2012-02-27
    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 number2010-021491-28
    A.3Full title of the trial
    A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months
    Studio Clinico di fase III randomizzato, in doppio cieco, controllato con comparatore attivo per studiare la sicurezza, la tollerabilita' e l'immunogenicita' di V419 nei neonati sani quando somministrato a 2, 4, e da 11 a 12 mesi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ND
    ND
    A.4.1Sponsor's protocol code numberV419-008
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/167/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSANOFI PASTEUR MSD S.N.C.
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMerck and Co
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur MSD S.N.C.
    B.5.2Functional name of contact pointClinical Development Director
    B.5.3 Address:
    B.5.3.1Street Address8, Rue Jonas Salk
    B.5.3.2Town/ cityLyon Cedex 07
    B.5.3.3Post code69367
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 4 37284000
    B.5.5Fax number+33 4 37284440
    B.5.6E-mailclinicaldevelopment@spmsd.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 namePR5I
    D.3.2Product code V419
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNTETANUS TOXOID
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERTUSSIS TOXOID
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    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 number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFilamentous Haemoagglutinin
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 INNPERTACTIN
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPATITIS B SURFACE ANTIGEN
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN (RDNA)
    D.3.9.4EV Substance CodeSUB20082
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name INFANRIX™ hexa
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals s.a.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Yes
    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 INNTETANUS TOXOID
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERTUSSIS TOXOID
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    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.3.8INN - Proposed INNFilamentous haemagglutinin
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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.3.8INN - Proposed INNPertactin
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 INNHEPATITIS B SURFACE ANTIGEN
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 holderWyeth Lederle Vaccines S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Yes
    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 INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB25373
    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.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB25371
    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.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
    D.3.9.1CAS number NA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB20574
    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.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB25370
    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.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 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: 4
    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 Rotarix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals s.a.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10000000
    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
    PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus.
    PR5I è sviluppato per fornire immunizzazione attiva contro la difterite, tetano, pertosse, poliomelite (causate da poliovirus Tipi 1, 2 e 3), patologie invasive causate da Haemofilus influenza tipo B ed infezione causata da tutti i sotto tipi del virus dell'epatite B.
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054183
    E.1.2Term Tetanus immunization
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019743
    E.1.2Term Hepatitis B virus (HBV)
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054181
    E.1.2Term Hepatitis B immunization
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10039242
    E.1.2Term Routine childhood immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the immunogenicity of PR5I when given at 2, 4, and 11 to 12 months of age.
    Valutare l'immunogenicità di PR5I quando somministrato ai mesi 2, 4, e da 11 a 12 mesi di età.
    E.2.2Secondary objectives of the trial
    1)to compare the post-infant series anti-PRP response elicited by PR5I to that of INFANRIX™ hexa. 2)To compare the immunogenicity resp. elicited by PR5I to that of INFANRIX™ hexa when given at 2,4,11 to 12 mm. 3)To evaluate the immunog. of Rotarix™ when administered concomitantly with PR5I4)To describe the safety profile associated with the administr.of each dose of PR5I or INFANRIX™ hexa when given concomitantly with Prevenar 13™ and Rotarix™.5)To describe fever occurring within 5 days after the administration of each dose and after all doses of PR5I or INFANRIX™ hexa when given concomitantly with Prevenar 13™ and Rotarix™ or RotaTeq™.6)To describe the %of subjects with solicited injection-site AEs and solicited systemic AEs within 5 dd after each dose and after all doses of PR5I or INFANRIX™ hexa when coadmin.with other recommended vaccines7)To summarize the incidence of SAEs
    Il disegno dello studio ha lo scopo di (1) valutare l'accettabilità e non inferiorità di PR5I rispetto al prodotto di controllo approvato, (2) valutare l'immunogenicità di Rotarix™ (vaccino antirotavirus, orale, vivo) somministrato in concomitanza e (3) descrivere i profili di sicurezza e tollerabilità di PR5I quando somministrato con vaccini pediatrici approvati di uso comune, con una posologia che prevede 2 dosi in età neonatale e 1 dose di richiamo (2+1).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be randomized and receive the first study vaccinations, subjects must meet all inclusion criteria. 1. Subject is a healthy infant and is greater than or equal to 46 days and less than or equal to 89 days of age on the day of vaccination. 2. Subject's parent(s)/legal representative understand the study procedures, alternate treatments available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. 3. Subject's parent(s)/legal representative are able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card [VRC]). 4. Subject is able to attend all scheduled visits and to comply with the study procedures. 5. Subject's parent(s)/legal representative have access to a telephone.
    1. Neonati sani da 46 a 89 giorni di vita al momento della vaccinazione 2. i genitori/legali rappresentanti del neonato devono aver compreso le procedure in studio, i trattamenti alternativi, i rischi e volontariamente acconsentire la partecipazione con consenso firmato 3.i genitori/legali rappresentanti del neonato devono leggere, capire, e completare questionari di studio4. i soggetti devono partecipare alle visite richieste ed essere complianti con le procedure dello studio 5.i genitori/legali rappresentanti del neonato devono avere a disposizione un telefono
    E.4Principal exclusion criteria
    To be randomized and receive the first study vaccinations, subjects must not meet any exclusion criteria. If a subject meets any of the exclusion criteria marked with an asterisk (*), the Day 1 visit may be rescheduled for a time when these criteria are no longer met. 1. Subject is currently participating or has participated in a study with an investigational compound or device within 4 weeks of expected first dose of PR5I/vaccine control(s). 2. Subject's parent(s)/legal representative plan to enroll the subject in another clinical study during the present study period. 3. Subject has history of congenital immunodeficiency or acquired immunodeficiency (e.g., HIV, splenomegaly). 4. Prior to study entry, subject has received or is expected to receive immunosuppressive agents (e.g., substances or treatments known to diminish immune response such as radiation therapy, antimetabolites, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporine, leflunomide [Arava™], TNF-α antagonists, monoclonal antibody therapies [including rituximab (Rituxan™)], intravenous gamma globulin [IVIG], antilymphocyte sera, or other therapy known to interfere with the immune response). 5. Subject has received (a) systemic immunomodulatory steroids (> the equivalent of 2 mg/kg total daily dose of prednisone) since birth, or (b) any dose of systemic immunomodulatory steroids within 7 days prior to entering study, or (c) is expected to require systemic immunomodulatory steroids through the course of the study. Subjects using non-systemic corticosteroids (e.g., topical, ophthalmic, inhaled) will be eligible for vaccination. 6. Subject has a history of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder. 7. Subject has a known or suspected hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines. XML File Identifier: lbrZgmmIUScxnG4Gy7HUW/wvzcU= Page 37/49 8. Subject has chronic illness that could interfere with study conduct or completion. 9. Subject has received any immune globulin, blood, or blood-derived products since birth. 10. Subject has received a dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry. 11. Subject has received, prior to enrollment, vaccination with any acellular pertussis (DTaP) or whole cell pertussis (DTwP) based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof. 12. *Subject has had a febrile illness within 24 hours prior to enrollment or a rectal temperature ≥38.0°C at Visit 1. 13. *Subject has been vaccinated with any non-study vaccine (e.g. inactivated, conjugated or live virus vaccine) within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment. 14. Subject has a coagulation disorder contraindicating intramuscular (IM) vaccination. 15. Subject has clinically significant findings on review of systems (by medical history) determined by the investigator or sub-investigator to be sufficient for exclusion. 16. Subject has developmental delay or neurological disorder (by medical history at study entry). 17. Subject or his/her mother has a medical history of HBsAg seropositivity. 18. Subject has a history of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection. 19. Subject's parent(s)/legal representative are unlikely to adhere to study procedures, keep appointments, or are planning to relocate during the study. 20. Any contraindication to the concomitant study vaccines
    1. Il soggetto sta attualmente partecipando o ha partecipato ad uno studio con un composto o un dispositivo sperimentale nelle 4 settimane precedenti la prima dose prevista di PR5I/vaccino/i di controllo. 2. i Genitori del soggetto o i rappresentanti legali intendono arruolare il soggetto in un altro studio clinico durante questo periodo di studio 3. Il soggetto ha una storia clinica di immunodeficienza congenita o immunodeficienza acquisita (per esempio HIV, splenomegalia). 4. Prima del suo ingresso nello studio, il soggetto ha ricevuto o deve ricevere agenti immunosoppressori (per esempio sostanze o trattamenti che notoriamente diminuiscono la risposta immune così come una terapia a radiazioni, antimataboliti, ciclofosfamide, azatiopriae, metotrexate e qualsiasi terapia chemioterapia, ciclosporina, leflunomide [AravaTM], antagonista TNF-α anticorpi monoclonali [incluso rituximab (RituxanTM)], globulina intravenosa gamma [IVIG] antilinfocite sera, o qualsiasi altra terapia che notoriamente interferisce con la risposta immunitaria). 5. Il soggetto ha ricevuto dalla nascita (a) steroidi immunomodulatori sistemici (&gt; l’equivalente di 2 mg/kg dose totale giornaliera di prednisone) o (b) qualsiasi dose di steroidi immunomodulatori sistemici entro 7 giorni prima di entrare nello studio o (c) si prevede che richiederà steroidi immunomodulatori sistemici durante il corso dello studio. I soggetti che utilizzano corticosteroidi non sistematici (esempio, topici, oftalmici, inalati) saranno eleggibili per la vaccinazione. 6. Il soggetto ha una storia clinica di leucemia, linfoma, melanoma maligno e disturbo mieloproliferativo. 7. Il soggetto ha una ipersensibilità nota o sospetta a uno qualsiasi dei componenti del vaccino o una storia clinica di reazioni a rischio di morte a vaccini contenenti le stesse sostanze dei vaccini di studio o vaccini di studio concomitanti. 8. I soggetti soffrono di malattie croniche che possono interferire con la condotta dello studio o il suo completamento. 9. Il soggetto ha ricevuto qualsiasi immune globulina, sangue o prodotti derivanti dal sangue dalla nascita 10. Il soggetto ha ricevuto una dose del vaccino monovalente epatite b o una combinazione di vaccini per epatite B prima di entrare nello studio 11. Il soggetto ha ricevuto, prima dell’arruolamento, il vaccino a base combinata di Pertosse acellulare (DTaP) o pertosse a cellule totali (DTwP), Influenza Emofiliaca di tipo b coniugata, poliovirus, coniugato pneumococco o prenumococco polisaccaride, vaccino rotavirus o sua combinazione. 12. * Il soggetto ha avuto una malattia febbrile entro le 24 ore prima dell’arruolamento o una temperatura rettale di &gt; 38.0°C alla visita 1. 13. * Il soggetto è stato vaccinato con un vaccino non in studio (esempio inattivo, coniugato o vaccino a virus vivo) entro 30 giorni prima dell’arruolamento, ad eccezione del vaccino influenzale inattivato, che è permesso 14 giorni o più prima dell’arruolamento. 14. Il soggetto ha un disturbo di coagulazione che controindica la vaccinazione intramuscolare (IM). 15. Il soggetto presenta degli accertamenti clinici di revisione sistema (dalla storia clinica) determinati dallo sperimentatore o sub sperimentatore sufficienti per l’esclusione. 16. Il soggetto ha un ritardo di sviluppo o disturbo neurologico (storia clinica o all’ingresso dello studio) 17. Il soggetto o la madre del soggetto ha una storia clinica di sieropositività HBsAg 18. Il soggetto ha una storia clinica di influenza emofiliaca di tipo B, epatite b, difteria, tenato, pertosse, poliomielite, rotavirus gastroenterite, o infezione invasiva pneumococco. 19. I genitori del soggetto/rappresentanti legali non sono disponibili ad aderire alle procedure di studio, a mantenere gli appuntamenti o stanno programmando un trasferimento durante lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for the acceptability hypothesis are vaccine induced antibody responses to all antigens contained in PR5I following the Toddler dose (~12 months). The primary endpoints for the non-inferiority hypothesis are vaccineinduced antibody responses against antigens that are contained in both PR5I and the control vaccine after the Toddler dose (~12 months) as listed in Table 2-3 of the protocol.
    Gli endpoint primari per l'ipotesi di accettabilità sono i vaccini che inducono la risposta anticorpale a tutti gli antigeni contenuti in PR5I seguendo la dose Toddler dei 12 mesi. Gli endpoint primari per l'ipotesi di non inferiorità sono i vaccini che inducono la risposta anticorpale a tutti gli antigeni contenuti in PR5I seguendo la dose dei 12 mesi, come elencato nella tabella 2-3 del protocollo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the toddler dose (12 months)
    Dopo la dose Toddler dei 12 mesi
    E.5.2Secondary end point(s)
    The endpoint for the secondary hypothesis testing of non-inferiority and superiority regarding PRP response is the proportion of subjects with anti-PRP level ≥1.0 μg/ml at Postdose 2. The endpoint for the secondary hypothesis testing of non-inferiority regarding antirotavirus IgA is the GMT at Postdose 2 in subjects receiving Rotarix
    L'endpoint per l'ipotesi secondaria del test di non-inferiorità e superiorità riguardo la risposta PRP è la proporzione di soggetti con livelli anti PRP≥1.0 μg/ml alpostdose 2. L'endpoint per l'ipotesi secondaria del test di non-inferiorità riguardo l'antirotavirus IgA è il GMT al Postdose 2 in soggetti che ricevono Rotarix
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the toddler dose (12 months)
    Dopo la dose Toddler di 12 mesi
    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
    tolerability, immunogenicity
    tolerabilità, 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months33
    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: 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) Yes
    F.1.1.4.1Number of subjects for this age range: 1300
    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 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
    all participants are infants
    tutti i partecipanti sono infanti
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1300
    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)
    NA
    NA
    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 Decision2011-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-09
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