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    Summary
    EudraCT Number:2016-002873-36
    Sponsor's Protocol Code Number:A3L31
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-07-08
    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 number2016-002873-36
    A.3Full title of the trial
    Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine at 2, 4, and 6 Months of Age versus Sanofi Pasteur's DTaP-IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed with Hep B at Birth
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DTaP-IPV-Hep B-PRP~T Combined Vaccine versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
    A.4.1Sponsor's protocol code numberA3L31
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02094833
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-6896
    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 SponsorSanofi Pasteur SA
    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 SA
    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 pointMedical Product Leader
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Pont Pasteur
    B.5.3.2Town/ cityLyon cedex 07
    B.5.3.3Post codeF-69367
    B.5.3.4CountryFrance
    B.5.6E-mailEmmanuel.Vidor@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.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDTaP-IPV-Hep B-PRP-T combined vaccine
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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 Pentaxim
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePentaxim
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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: 3
    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 Euvax B
    D.2.1.1.2Name of the Marketing Authorisation holderLG Life Sciences
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 nameEuvax B
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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
    Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b infection, Poliomyelitis, and Hepatitis B
    E.1.1.1Medical condition in easily understood language
    Diphtheria, Tetanus, Whooping cough, Haemophilus Influenzae, Polio, and Hepatitis B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hepatitis B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A (DTaP-IPV-Hep B-PRP-T combined vaccine) versus Group B (DTaP-IPV//PRP~T vaccine [Pentaxim]), one month after the third dose of combined vaccines.
    E.2.2Secondary objectives of the trial
    Immunogenicity:
    To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.

    Safety:
    To study the safety after each and any dose of vaccines administered in the two vaccination schemes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
    1) Aged 30 to 40 days on the day of the first study visit
    2) Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
    3) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
    4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
    5) Born to known hepatitis B surface antigen (HBsAg) seronegative mother: documented HBsAg negative status during the last trimester of pregnancy (or post-birth) or documented HBsAg negative and HBsAb positive status before last trimester of pregnancy
    6) Have received one documented dose of Hep B vaccine at birth according to the national recommendations
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial
    investigating a vaccine, drug, medical device, or medical procedure
    2) Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin [BCG] vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
    3) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
    4) Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
    5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
    6) Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
    7) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically,
    serologically, or microbiologically
    8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
    9) Known thrombocytopenia, as reported by the parent/legally acceptable representative
    10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
    11) In an emergency setting, or hospitalized involuntarily
    12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    13) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
    14) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    15) History of seizures
    E.5 End points
    E.5.1Primary end point(s)
    One month after the third dose of study combined vaccines (Day 180, Visit 5, at approximately 7 months of age):
    • anti-Diphtheria antibody (Ab) concentrations ≥ 0.01 International Units (IU)/mL
    • anti-Tetanus Ab concentrations ≥ 0.1 IU/mL
    • anti-PRP Ab concentrations ≥ 0.15 μg/mL
    • anti-poliovirus 1, 2, and 3 Ab titers ≥ 8 (1/dilution [dil])
    • ≥ 4-fold increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from 1 month pre-dose 1 (Visit 1) to 1 month post-dose 3 (Visit 5)
    • anti-Hepatitis B Ab concentrations ≥ 10 mIU/mL
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month post-dose 3 of study combined vaccines (Day 180)
    E.5.2Secondary end point(s)
    Immunogenicity:
    At Day 0 (Visit 1, at 1 month of age), before the first dose of vaccines:
    • anti-Diphtheria Ab concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL
    • anti-Hepatitis B Ab concentrations ≥ 10 mIU/mL
    • individual Ab concentrations: anti-PT, anti-FHA, anti-Hep B, anti-D
    • anti-PT and anti-FHA Ab concentrations ≥ LLOQ

    One month after the third dose of study vaccine (Day 180, Visit 5, at approximately 7 months of age):
    • anti-Diphtheria Ab concentrations ≥ 0.1 IU/mL
    • anti-Tetanus Ab concentrations ≥ 0.01 IU/mL
    • anti-PRP Ab concentrations ≥ 1.0 μg/mL
    • vaccine response for PT and FHA antigens defined as post-dose 3 anti-PT and anti-FHA Ab concentrations in ELISA units (EU)/mL ≥ 4 x lower limit of quantitation (LLOQ) if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 xLLOQ
    • ≥ 2-fold increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from 1 month pre-dose 1 (Vis it 1) to 1 month post-dose 3 (Visit 5)
    • anti-PT and anti-FHA Ab concentrations ≥ 5 EU/mL, ≥ 10 EU/mL, and ≥ 25 EU/mL
    • individual antibody concentrations/titers: all antibodies
    • individual post-/pre-primary vaccination Ab concentration ratios for anti-PT, anti-FHA, anti-Hep B, and anti-D

    Safety:
    • Occurrence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any vaccination
    • Occurrence of solicited (prelisted in the subject’s diary card and electronic Case Report Form [CRF]) injection site and systemic reactions occurring through 7 days (Day 0 to Day 7) after each and any vaccination
    • Occurrence of unsolicited AEs up to 30 days after each and any vaccination, as well as up to 30 days after Visit 1 for subjects in Group A
    • Occurrence of serious adverse events (SAEs) throughout the trial
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    Pre-dose (Day 0) and 1 month post-dose 3 of study combined vaccines (Day 180)

    Safety:
    Unsolicited systemic adverse events, 30 minutes post-each and any vaccination
    Solicited injection site and systemic reactions, Day 0 up to Day 7 post-each and any vaccination
    Unsolicited AEs, Day 0 up to Day 30 post-each and any vaccination
    Serious adverse events, Day 0 up to Day 180 post-each and any vaccination
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    DTaP-IPV//PRP~T combined vaccine (Pentaxim) and Recombinant hepatitis B monovalent vaccine (Euvax B)
    E.8.2.4Number of treatment arms in the trial2
    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
    Korea, Republic of
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months6
    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: 310
    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: 310
    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 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 No
    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 310
    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
    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: Korea, Republic of
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