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    Summary
    EudraCT Number:2011-004449-42
    Sponsor's Protocol Code Number:A3L24
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-04-10
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-004449-42
    A.3Full title of the trial
    Multi-center, randomized, observer blinded, Phase III trial in 1,376 infants, using Infanrix hexa™ as the control vaccine. Four-arm trial with subjects randomly allocated to receive 1 of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine (consistency testing), or the licensed control vaccine
    Infanrix hexa™ (non-inferiority testing). All subjects will receive concomitant administration of Prevenar™ and Rotarix™ with either the DTaP-IPV-Hep B-PRP-T vaccine or Infanrix hexa™.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly with Prevenar™ and Rotarix™
    A.4.1Sponsor's protocol code numberA3L24
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01177722
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1111-5801
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/015/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur S.A
    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 S.A
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur SA
    B.5.2Functional name of contact pointDirector, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address1541, Avenue Marcel Mérieux
    B.5.3.2Town/ cityMarcy l'étoile
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)4 37 37 58 53
    B.5.5Fax number33(0)4 37 37 74 38
    B.5.6E-maileduardo.santos-lima@sanofipasteur.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 nameHexaxim
    D.3.2Product code DTaP-IPV-HepB-PRP-T vaccine
    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.3.9.2Current 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 typenot less then
    D.3.10.3Concentration number20
    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 typenot less then
    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 namePERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB20298
    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 codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25669
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25670
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25671
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHep B
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB25275
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInfanrix hexa
    D.3.4Pharmaceutical form Powder and suspension 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.3.9.2Current 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 typenot less then
    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 typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25669
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25670
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25671
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHep B
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB25275
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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.3.9.3Other descriptive namePERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB20298
    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.3.9.3Other 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 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
    Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus
    E.1.1.1Medical condition in easily understood language
    Active immunisation against diphtheria,tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021430
    E.1.2Term Immunisation
    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 10036897
    E.1.2Term Prophylactic vaccination
    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 HLT
    E.1.2Classification code 10021431
    E.1.2Term Immunisations
    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 HLGT
    E.1.2Classification code 10043413
    E.1.2Term Therapeutic procedures and supportive care NEC
    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 demonstrate the equivalence of immunogenicity on three lots of DTaP-IPV-Hep B-PRP-T vaccine (final bulk product [FBP]) one month after a three-dose primary series (2, 4 and 6 months) when co-administered with Prevenar™ and Rotarix™ , in terms of immunoresponses evaluated by:
    - Geometric Means of Titers (GMTs) for Hep B.
    - Seroprotection rates for D, T, Hep B, PRP, and polio and seroresponse rates for anti-PT and anti-FHA.
    - To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa™ vaccine in terms of seroprotection or seroresponse rates to all antigens, one month after a three-dose primary series when co-administered with Prevenar™ and Rotarix™.
    E.2.2Secondary objectives of the trial
    Immunogenicity
    - To describe in each group the immunogenicity parameters for all antigens for each vaccine

    Safety
    To assess the safety profile in each group, for each vaccine, in terms of incidence of:
    - Unsolicited systemic adverse events (AEs) in the first 30 minutes after each injection.
    - Solicited injection site (except Rotarix™) and systemic adverse reactions (ARs) in the first 7 days after each injection.
    - Unsolicited non-serious AEs in the first 30 days after each injection.
    - Serious adverse events (SAEs) during the trial (including the 6-month follow-up period).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Two-month old infants (55 to 65 days of age) on the day of inclusion.
    2) Born at full term of pregnancy (≥37 weeks) with a birth weight ≥2.5 kg.
    3) Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements.
    4) Able to attend all scheduled visits and to comply with all trial procedures.
    5) Received Hep B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.
    E.4Principal exclusion criteria
    1) Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
    2) Planned participation in another clinical trial during the present trial period.
    3) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy within the preceding 3 months, or long-term systemic corticosteroid therapy.
    4) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
    5) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
    6) Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
    7) Any vaccination before trial vaccination (except Hep B and BCG given at birth).
    8) Any planned vaccination until one month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines and for pandemic influenza vaccination, which may be received at least two weeks before each study vaccine dose).
    9) Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hep B infection(s) (confirmed either clinically, serologically or microbiologically).
    10) Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
    11) Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity.
    12) Laboratory-confirmed or clinical suspicion of coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intra-muscular (IM) vaccination.
    13) History of seizures or encephalopathy.
    14) Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection, on the day of inclusion, according to the Investigator judgment.
    E.5 End points
    E.5.1Primary end point(s)
    The following serological endpoints will be assessed 1 month after the third dose of the primary series (V06, D140) for the lot-to-lot consistency and non-inferiority analyses:
    - Antibody (Ab) titers for Hep B.
    Seroprotection rates for D, T, Hep B, PRP, and polio with the following endpoints:
    - Anti-D and anti-T Ab titers > or =0.01 IU/mL.
    - Anti-Hep B Ab titers > or =10 mIU/mL.
    - Anti-PRP Ab titers > or =0.15 µg/mL.
    - Anti-polio 1, 2, and 3 Ab titers > or =8 (1/dil).
    Seroresponse rates for anti-PT and anti-FHA with the following endpoints:
    - Response to pertussis (PT, FHA) antigens defined as anti-PT or anti-FHA > or =Lower Limit of Quantitation (LLOQ) in initially seronegative subjects, or at least persistence (post-titer > or = pre titer) of the antibody titer in initially seropositive subjects (titer > or =LLOQ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The above serological endpoints will be assessed 1 month after the third dose of the primary series (V06, D140) for the lot-to-lot consistency and non-inferiority analyses
    E.5.2Secondary end point(s)
    Immunogenicity:
    Endpoints for the immune response (descriptive) will include:
    - Ab titers for D, PT, FHA, Hep B and rotavirus valences at V01.
    - Ab titers above a cut-off (V01):
    - Anti-D Ab titers > or =0.01 IU/mL and > or =0.1 IU/mL
    - Anti-PT Ab titers > or =LLOQ
    - Anti-FHA Ab titers > or =LLOQ
    - Anti-Hep B Ab titers > or =10 mIU/mL and > or =100 mIU/mL
    - Anti-rotavirus (Anti-RV) IgA > or =20 U/mL (in a subset of subjects only).
    - Ab titers for Rotarix™ valence at V04.
    - Ab titers above a cut-off (V04):
    - Anti-RV IgA > or =20 U/mL (in a subset of subjects only).
    - Ab titers for each valence at V06 except Rotarix™.
    - Ab titers above a cut-off (V06):
    - Anti-D antibody titers > or =0.1 IU/mL and > or =1.0 IU/mL.
    - Anti-T antibody titers > or =0.1 IU/mL and > or =1.0 IU/mL.
    - Anti-Hep B Ab titers > or =100 mIU/mL.
    - Anti-PRP Ab titers > or =1.0 µg/mL.
    - Anti-PT Ab titers > or =4 EU/mL
    - Anti-FHA Ab titers > or =4 EU/mL
    - Anti-pneumococcal serotype 4, 6B, 9V, 14, 18C, 19F and 23F titers > or =0.35 µg/mL (in a subset of subjects only).
    - Ab individual titer ratios for anti-D and Hep B (V06/V01).
    - Ab individual titer ratios for anti-PT and anti-FHA (V06/V01).
    - Ab individual titers ratios for anti-rotavirus (V04/V01).
    - Seroconversion for anti-RV IgA defined as anti-RV IgA > or =20 U/mL, in subject seronegative at pre-dose1 (V04/V01).
    - Seroconversion for anti PT and anti FHA, defined as anti PT and anti FHA > or =four-fold Ab titers increase from V01 to V06

    Safety:
    - Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, severity, and relationship to vaccination for any unsolicited systemic adverse events reported in the 30 minutes after each vaccination.
    - Occurrence, time to onset, number of days of occurrence, and severity for solicited (prelisted in the subject diary and electronic case report form [eCRF]) injection site and systemic reactions occurring up to 7 days after each vaccination.
    - Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, and relationship to vaccination (for systemic adverse events only) of unsolicited (spontaneously reported) adverse events up to 30 days after each vaccination.
    - Occurrence of SAEs throughout the trial (including the 6 months follow up period).

    Effect of prophylactic antipyretics use :
    - Ab titers for each valences of DTaP IPV-Hep B-PRP-T vaccine group only
    - Ab titers above a cut-off (V02) for:
    - Anti-D and anti-T antibody titers > or = 0.01, > or = 0.1 IU/mL and > or = 1.0 IU/mL
    - Anti-Hep B Ab titers > or = 10 and > or = 100 mIU/mL
    - Anti-PRP Ab titers > or = 0.15 and > or = 1.0 µg/mL
    - Anti-poliovirus 1, 2, and 3 Ab titers > or = 8 (1/dil)
    - Anti-PT Ab titers > or =4 EU/mL
    - Anti-FHA Ab titers > or =4 EU/mL
    Seroresponse rates for anti-PT and anti-FHA with the following endpoints:
    - Response to pertussis (PT, FHA) antigens defined as anti-PT or anti-FHA > or =LLOQ in initially seronegative subjects, or at least persistence (post-titer > or = pre titer) of the Ab titer in initially seropositive subjects (titer > or =LLOQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    A blood sample of approximately 4 mL will be taken at 2 months of age (BL1 - V01),
    a 4-mL blood sample at 5 months of age (BL2 - V04) in a subset of subjects, and a 5-mL blood sample at 7 months of age (BL3 - V06).
    There will be a total duration of 10 months for each subject (including a 6-month safety follow-up after the last injection).
    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) 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    blind-observer
    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 trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Colombia
    Costa Rica
    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
    end of the trial = LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 1376
    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: 1376
    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
    Vulnerable pop (enfants): ICF signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1376
    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)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Colombia
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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