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    EudraCT Number:2016-002089-29
    Sponsor's Protocol Code Number:A3L33
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-05-12
    Trial results View results
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    A. Protocol Information
    A.2EudraCT number2016-002089-29
    A.3Full title of the trial
    Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10, and 14 Weeks of Age in Infants in India Who Previously Received a Dose of Hepatitis B Vaccine at Birth
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
    A.4.1Sponsor's protocol code numberA3L33
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01948193
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-6936
    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.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.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 Address2, avenue Pont Pasteur
    B.5.3.2Town/ cityLyon cedex 07
    B.5.3.3Post codeF-69367
    B.5.4Telephone number33(0) 437 65 67 99
    B.5.5Fax number33(0) 437 37 00 00
    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. name Hexaxim™
    D. 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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] - 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 evaluate the immunogenicity of the study vaccine in terms of seroprotection (diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2, and 3, Haemophilus influenza type b [Hib] polysaccharide [PRP], hepatitis B [Hep B]) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) one month after the third dose
    E.2.2Secondary objectives of the trial
    To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose

    To describe the safety after each and any doses of the study vaccine
    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 between 42-56 days (6 to 8 weeks) on the day of inclusion
    2) Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
    3) Informed consent form signed by the parent(s) or any 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 HBsAg seronegative mother (documented laboratory result of HBsAg assay from maternal blood sample performed during
    last trimester of pregnancy available)
    6) Have received one documented dose of Hep B vaccine and OPV from birth as per national recommendations
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Participation in another clinical trial 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 the first trial vaccination (except BCG vaccine) or planned receipt of any other
    vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
    3) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of OPV as per national
    recommendations) and hepatitis B (except the birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or another
    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 Hib infections (confirmed either clinically, serologically or
    7) Known personal or maternal history of HIV or hepatitis C seropositivity
    8) 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
    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 (axillary
    temperature ≥38°C) on the day of inclusion (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, relatives 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 vaccine (D90, Visit 4, at approximately 18 weeks of age):
    • Anti-diphtheria antibody (Ab) concentrations ≥ 0.01 International Units (IU)/mL
    • Anti-tetanus Ab concentrations ≥ 0.01 IU/mL
    • Anti-PRP Ab concentrations ≥ 0.15 μg/mL
    • Anti-poliovirus 1, 2 and 3 Ab titers ≥ 8 (1/dilution [dil])
    • 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 x LLOQ
    • anti-Hep B Ab concentrations ≥ 10 mIU/mL
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints were evaluated one month after the third dose of study vaccine (Day 90, Visit 4, at approximately 18 weeks of age).
    E.5.2Secondary end point(s)
    At baseline (Day 0, Visit 1), before the first dose:
    1) Anti-diphtheria Ab concentrations ≥ 0.01 and 0.1 IU/mL
    2) Anti-Hep B Ab concentrations ≥ 10 mIU/mL
    3) Pertussis (PT, FHA) Ab concentrations ≥ LLOQ
    4) Individual diphtheria, Hep B, PT and FHA antibody concentrations/titers

    One month after the third dose of study vaccine (Day 90, Visit 4, at approximately 18 weeks of age):
    5) Anti-diphtheria Ab concentrations ≥ 0.1 IU/mL
    6) Anti-tetanus Ab concentrations ≥ 0.1 IU/mL
    7) Anti-PRP Ab concentrations ≥ 1.0 μg/mL
    8) Individual Abs concentrations/titers: all Abs
    9) ≥ 4-fold and ≥ 2-fold increase in anti-PT and anti-FHA Ab
    concentrations (EU/mL) from pre-dose 1 (Visit 1) to one month postdose 3 (Visit 4)
    10) Anti-PT and anti-FHA Ab concentrations ≥ 5 EU/mL, ≥ 10 EU/mL and ≥ 25 EU/mL
    11) Individual post-/pre-primary vaccination Ab concentration (EU/mL) ratios for all Abs

    12) Occurrence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any vaccination(s).
    13) Occurrence of solicited (prelisted in the subject’s diary card [DC] and Case Report Form) injection site and systemic reactions occurring through 7 days (D0-D7) following each and any vaccination(s).
    14) Occurrence of unsolicited AEs through 30 days following each and any vaccination(s).
    15) Occurrence of serious adverse events (SAEs) throughout the trial, Visit 1 to Visit 4.

    Other endpoints recorded or derived will be described at the time of
    statistical analysis. Depending on the item, these could include : nature
    (Medical Dictionary for Regulatory Activities preferred term), time of onset,
    duration, number of days of occurrence, grade of severity, relationship to
    vaccine, action taken, whether the
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints 1 through 4: Baseline (Day 0, Visit 1)
    Endpoints 5 through 11: One month after the third dose of study vaccine (Day 90, Visit 4, at approximately 18 weeks of age)

    Endpoint 12: 30 minutes after each and any vaccination
    Endpoint 13: Day 0 up to Day 7 post each and any vaccination
    Endpoint 14: Day 0 up to Day 30 post each and any vaccination
    Endpoint 15: Day 0 up to Day 90
    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. 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.8.2.4Number of treatment arms in the trial1
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    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: 177
    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. of subjects for this age range: 177
    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 177
    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)
    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: India
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