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    Summary
    EudraCT Number:2017-004181-10
    Sponsor's Protocol Code Number:A3L35
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-12-04
    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 number2017-004181-10
    A.3Full title of the trial
    Immunogenicity and Safety of Sanofi Pasteur’s DTaP IPV HB PRP~T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or within 1 Week after Birth
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of Sanofi Pasteur’s Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or within 1 Week after Birth
    A.4.1Sponsor's protocol code numberA3L35
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02428491
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1143-8177
    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 pointGlobal Medical Affairs
    B.5.3 Address:
    B.5.3.1Street Address14 Espace Henry Vallée
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69007
    B.5.3.4CountryFrance
    B.5.6E-mailolga.lyabis@Sanofi.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 Hexacima
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    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 nameHexacima
    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
    Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 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 diphtheriae, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b
    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 20.0
    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 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10021430
    E.1.2Term Immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the safety profile after each and all doses of the study vaccine
    E.2.2Secondary objectives of the trial
    • To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3 dose Primary Series (2, 3 and 4 MoA) with the immune response to all antigens induced by the same study vaccine outside Vietnam (Cohort 1)
    • To evaluate the immunogenicity of the study vaccine one month after the 3-dose Primary Series (Cohort 1)
    • To describe the persistence of all antibodies (Abs) before receipt of the booster vaccination (Cohort 1)
    • To evaluate the immunogenicity of the study vaccine one month after the booster (Cohort 1)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged 61 to 91 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) ICF has been signed and dated by the parent(s) or other legally acceptable representative(s) (and by an independent witness if required by local regulations)
    4) Subject and parent(s)/legally acceptable representative(s) were able to attend all scheduled visits and to comply with all trial procedures
    5) Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations)
    E.4Principal exclusion criteria
    1) Participation in the 4 weeks preceding the first trial vaccination 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 the first trial vaccination or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for BCG vaccination (any administration of oral polio vaccine [OPV] in the context of OPV-National Immunisation Days [NIDs] does not fall within the scope of this exclusion criterion)
    3) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion)
    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) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
    7) Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
    8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
    9) Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s)
    10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
    11) History of seizures
    12) In an emergency setting, or hospitalized involuntarily
    13) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    14) 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.
    15) Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
    E.5 End points
    E.5.1Primary end point(s)
    1) Occurrence of all unsolicited systemic AEs reported in the 30 minutes after each and all vaccination(s).
    2) Occurrence of solicited (prelisted in the subject’s DC and CRF) injection site and systemic reactions following each and all vaccination(s).
    3) Occurrence of unsolicited AEs following each and all vaccination(s).
    4) Occurrence of SAEs throughout the Primary Series period and booster period. In addition, all related SAEs, unrelated deaths and life-threatening SAEs were collected between D90 and D425.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 30 minutes after each and all vaccination(s)
    2) D0-D7 following each and all vaccination(s)
    3) Through 30 days following each and all vaccination(s)
    4) All SAEs throughout the Primary Series trial period (from D0 to D90) and throughout the booster trial period (D425 to D455). In addition, all related SAEs, unrelated deaths and life-threatening SAEs are to be collected between D90 and D425.
    E.5.2Secondary end point(s)
    At baseline, before the first dose of study vaccine (D0, at approximately 2 months of age [MoA]):
    • Anti-PT and anti-FHA Ab concentrations ≥ Lower Limit of Quantitation (LLOQ) and ≥ 4 x LLOQ
    • Anti-PT and anti-FHA individual Ab concentrations
    One month after the third dose of study vaccine (D90, at approximately 5 MoA):
    • Anti-D Ab concentrations ≥ 0.01 and ≥ 0.1 IU/milliliter (mL) International Units (IU)/mL
    • Anti-T Ab concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL
    • Anti-PRP Ab concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
    • Anti-poliovirus 1, 2, and 3 Ab titers ≥ 8 (1/dilution [dil])
    • Vaccine response for pertussis toxoid (PT) and FHA antigens defined as post third dose anti-PT and anti-FHA Ab concentrations ≥ 4 x LLOQ if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ
    • ≥ 4-fold* increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from pre-dose 1 to one month post-dose 3
    • Individual Ab concentration ratios for anti-PT and FHA (post-Dose 3/pre-Dose 1)
    • Anti-Hep B Ab concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL
    • Individual Ab concentrations/titers: all Abs
    * ≥ 4-fold increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from pre-dose 1 to one month post-dose 3 corresponds to seroconversion.
    Booster vaccination:
    Before the booster dose of study vaccine (D425, at 16 to 17 MoA):
    • Individual Ab concentrations/titers: all Abs
    • Anti-PT and anti-FHA Ab concentrations ≥ LLOQ and ≥ 4 x LLOQ
    • Anti-D Ab concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL
    • Anti-T Ab concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL
    • Anti-polyribosyl ribitol phosphate (PRP) Ab concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
    • Anti-poliovirus 1, 2, and 3 Ab titers ≥ 8 (1/dil)
    • Anti-Hep B Ab concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL
    One month after the booster dose of study vaccine (D455, at 17 to 18 MoA):
    • Anti-D Ab concentrations ≥ 0.01 IU/mL, ≥ 0.1 IU/mL, and 1.0 IU/mL
    • Anti-T Ab concentrations ≥ 0.01 IU/mL, ≥ 0.1 IU/mL, and 1.0 IU/mL
    • Anti-polyribosyl ribitol phosphate (PRP) Ab concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
    • Anti-poliovirus 1, 2, and 3 Ab titers ≥ 8 (1/dil)
    • Vaccine response for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) antigens defined as post-fourth dose anti-PT and anti-FHA Ab concentrations ≥ 4 x LLOQ, if pre-vaccination concentration < 4 x LLOQ or ≥ pre-vaccination concentration, if pre-vaccination concentrations ≥ 4 x LLOQ
    • Booster response for PT and FHA antigens: ≥ 4-fold increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from pre-Booster to one month post Booster if pre-Booster Ab concentrations < 4x LLOQ; or ≥ 2 fold increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from pre-Booster to one month post-Booster if pre Booster Ab concentrations ≥ 4x LLOQ
    • ≥ 4-fold* increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from pre-dose 4 to one month post-dose 4
    • Ab individual concentration ratios for all antigens (one month post Dose 4/pre-Dose 4)
    • Anti-Hep B Ab concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL
    • Individual Ab concentrations/titers: all Abs
    * ≥ 4-fold increase in anti-PT and anti-FHA Ab concentrations (EU/mL) from pre-dose 4to one month post-dose 4 corresponds to seroconversion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline before the first dose of study vaccine (D0), before the booster dose of study vaccine (D425), and one month after the booster dose (D455)
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Vietnam
    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 months15
    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: 354
    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: 354
    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
    The Informed Consent Form was signed and dated by the parent(s) or other legally acceptable representative(s) (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 354
    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: Vietnam
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