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    Summary
    EudraCT Number:2006-001095-21
    Sponsor's Protocol Code Number:A5I16
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-04-19
    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 number2006-001095-21
    A.3Full title of the trial
    Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Infanrix®-IPV+Hib when Both Vaccines are Co-Administered with Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Compare PEDIACEL® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
    A.4.1Sponsor's protocol code numberA5I16
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00343421
    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 Inc.
    B.1.3.4CountryUnited States
    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 Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur Inc.
    B.5.2Functional name of contact pointClinical Team Leader
    B.5.3 Address:
    B.5.3.1Street Address1 Discovery Drive
    B.5.3.2Town/ citySwiftwater
    B.5.3.3Post code18370
    B.5.3.4CountryUnited States
    B.5.4Telephone number1570957 3570
    B.5.6E-mailEmilia.jordanov@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 Yes
    D.2.1.1.1Trade name PEDIACEL: Diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and H. influenzae type b conjugate vaccine (adsorbed)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    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 namePEDIACEL
    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 Infanrix–-IPV+Hib: Diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and adsorbed conjugated H. influenzae type b vaccine.
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    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 nameInfanrix–-IPV+Hib
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 Prevenar: pneumococcal saccharide conjugated vaccine, adsorbed
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    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 namePrevenar
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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
    Pertussis, adsorbed diphtheria and tetanus toxoids, inactivated poliomyelitis and polysaccharide of H. influenza type b bound to tetanus toxoid
    E.1.1.1Medical condition in easily understood language
    Pertussis, diphtheria, tetanus, polio, and polysaccharide of H. influenza type b bound to tetanus toxoid
    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
    Primary Phase
    1) To compare the post-Dose 3 immunogenicity of PEDIACEL to Infanrix–-IPV+Hib, when both are co-administered with Prevenar to infants at 2, 3 and 4 months of age.
    2) To compare the post-Dose 3 immunogenicity of Prevenar co-administered with PEDIACEL to the post-Dose 3 immunogenicity of Prevenar co-administered with Infanrix-IPV+Hib, in infants at 2, 3 and 4 months of age.
    3) To describe the post-Dose 3 pertussis antibody responses in both study groups.

    Booster Phase
    Not applicable
    E.2.2Secondary objectives of the trial
    Primary Phase
    1) To describe the safety of PEDIACEL and Infanrix–-IPV+Hib after each vaccination when they are co-administered with Prevenar to infants at 2, 3, 4 months of age.
    2) To describe the post-Dose 3 antibody responses to all the antigens contained in PEDIACEL, Infanrix–-IPV+Hib and Prevenar vaccines.

    Booster Phase
    1) To describe the safety of PEDIACEL and Infanrix–-IPV+Hib after the Dose 4 (booster) vaccination when they are co-administered with Prevenar to infants and toddlers at 12 to 18 months of age
    2) To describe the post-Dose 4 (booster) antibody responses to all the antigens contained in PEDIACEL, Infanrix-IPV+Hib, and Prevenar vaccines
    3) To compare the post-Dose 4 (booster) immunogenicity of concomitant administration of PEDIACEL and Prevenar to concomitant administration of Infanrix-IPV+Hib and Prevenar vaccines
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A potential subject had to meet all of the following criteria to be considered for trial enrolment:
    1. Infants 55 to 75 days old, inclusive on the day of first vaccination.
    2. Born at full term of pregnancy (> 37 weeks).
    3. ICF signed by the parent(s) or the legal guardian (according to local regulations).
    4. Parent(s) or the legal guardian was able to read and write in the local language.
    5. Parent(s) or the legal guardian was able to attend all scheduled visits and to comply with the study procedures.
    E.4Principal exclusion criteria
    A potential subject meeting any of the following criteria was ineligible for trial
    enrolment:
    1. Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours.*
    2. Moderate or severe acute illness with or without fever.*
    3. Participation in another clinical trial in the 30 days preceding first study vaccination.
    4. Planned participation in another clinical trial during the present study period.
    5. Received diphtheria, tetanus, pertussis, poliomyelitis, H. influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination.
    6. Received any vaccination during the following periods:
    - from 30 days prior to Visit 1 (BS1+Vac1) up to and including Visit 4 (BS2)
    - from 30 days prior to Visit 5 (BS3+Vac4) up to and including Visit 6 (BS4).
    7. Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days.
    8. Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
    9. History of life-threatening reaction(s) (such as encephalopathy, hypotonichyporesponsive episode (HHE), rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines.
    10. Blood or blood-derived products (immunoglobulins) received since birth.
    11. Known human immunodeficiency virus seropositivity.
    12. Known thrombocytopenia or other bleeding disorder contraindicating IM vaccination.
    13. History of encephalopathy, seizures or progressive, evolving or unstable neurological condition.
    14. Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.
    *The Investigator was to postpone the vaccination until the condition resolved.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Phase
    The parameters for the primary endpoints were:
    1. Proportion of subjects achieving one month (28-42 days) post-Dose 3 seroprotective titres to each of the following antigens:
    - PRP (at the level of ≥ 0.15 μg/mL)
    - Diphtheria toxoid (at the level of ≥ 0.01 IU/mL)
    - Tetanus toxoid (at the level of ≥ 0.01 IU/mL)
    - Poliovirus types 1, 2 and 3 (at a titre of ≥ 1:8 dilution [dil]).
    2. Proportion of subjects achieving one month (28-42 days) post-Dose 3 seroprotective titers to each of the following pneumococcal serotypes: 4, 6B, 9V, 14, 18C, 19F and 23F (at the level of ≥ 0.35 μg/mL).
    3. Proportion of subjects achieving one month (28-42 days) post-Dose 3 seroresponse (defined as seropositivity, i.e. antibodies above the assay cut-off point (lower limit of quantitation [LLOQ]) at one month post-Dose 3 in subjects with baseline antibodies below the cut-off point or at least persistence of baseline antibody concentration in subjects who were initially seropositive to each of the following pertussis antigens:
    - Pertussis toxoid (PT)
    - Filamentous haemagglutinin (FHA)
    - Pertactin (PRN)
    - Fimbriae types 2 and 3 (FIM).

    Booster Phase
    Not applicable
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month post-dose 3 for all primary endpoints
    E.5.2Secondary end point(s)
    Primary Phase
    The parameters for the secondary endpoints were:
    Safety Assessment
    1. The number and percentage of subjects with any of the following:
    a) Solicited injection site reactions (tenderness, erythema and swelling) collected from Day 0 to Day 7 after each vaccination
    b) Solicited systemic reactions (fever, vomiting, abnormal crying, drowsiness, loss of appetite and irritability) collected from Day 0 to Day 7 after each vaccination
    c) Unsolicited adverse events (AEs) collected in the diary card for 28 days after each vaccination
    d) Serious adverse events (SAEs) reported from the time the informed consent form (ICF) was signed and throughout the course of the study.
    A diary card was used to record solicited reactions (Day 0 to Day 7) and unsolicited AEs (Day 0 to Day 28) after each vaccination.

    Immunogenicity Assessment
    2. a. Geometric mean titers (GMTs) for antibodies against all antigens (PRP, diphtheria toxoid, tetanus toxoid, PT, FHA, PRN, FIM, poliovirus types 1, 2 and 3, and pneumococcal serotypes: 4, 6B, 9V, 14, 18C, 19F and 23F) in both groups at one month (28-42 days) post-Dose 3.
    b. Proportion of subjects achieving one month (28-42 days) post-Dose 3 seroprotective titres to each of the following antigens:
    - PRP (at the level of ≥ 1.0 μg/mL)
    - Diphtheria toxoid (at the level of ≥ 0.1 IU/mL)
    - Tetanus toxoid (at the level of ≥ 0.1 IU/mL)

    Booster Phase
    1) Geometric mean titers (GMTs) for diphtheria toxoid, tetanus toxoid, pertussis antigens (PT, FHA, PRN, and FIM), PRP, poliovirus antigens (Type 1, 2 and 3), and pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F pre-Dose 4 and at one month (28-42 days) post-Dose 4 vaccination will be calculated by vaccine group.
    2) Proportion of subjects with a booster response to pertussis antigens from pre-Dose 4 to one month (28-42 days) post-Dose 4 (booster) vaccination with respect to pre-Dose 4 vaccination:
    - Pertussis toxoid
    - Filamentous haemagglutinin
    - Pertactin
    - Fimbriae types 2 and 3
    3) Proportion of subjects achieving one-month (28-42 days) post-Dose 4 vaccination seroprotective titres to each of the following antigens will be calculated by vaccine group and the difference in proportions between both groups and the 95% CI will be computed:
    - PRP (at the level of ≥ 1.0 µg/mL)
    - Diphtheria toxoid (≥ 0.1 IU/mL)
    - Tetanus toxoid (at the level of ≥ 0.1 IU/mL)
    - Polio 1, 2, and 3 (at a titre of ≥ 1:8 dil)
    - Pneumococcal serotypes 4, 6B, 9V, 14, 18C 19F and 23F (at the level of ≥ 0.35 µg/mL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary Phase
    1a) Day 0 up to Day 7 post-each vaccination
    1b) Day 0 up to Day 7 post-each vaccination
    1c) Day 0 up to Day 28 post-each vaccination
    1d) Day 0 up to Day 28 post-dose 3

    Booster Phase
    1) Pre-dose 4 and 1 month post-dose 4 (booster)
    2) Pre-dose 4 and 1 month post-dose 4 (booster)
    3) 1 month post-dose 4 (booster)
    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 Yes
    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
    Infanrix-IPV+Hib
    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
    France
    Poland
    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 months17
    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: 588
    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: 588
    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 560
    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: France
    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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