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    Summary
    EudraCT Number:2005-004133-17
    Sponsor's Protocol Code Number:A5I15
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-18
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2005-004133-17
    A.3Full title of the trial
    A randomised, controlled, double blind study of the 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 given to infants using a three dose immunisation schedule (“Nordic schedule” 3-5-12 months)
    A.4.1Sponsor's protocol code numberA5I15
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur Incorporated
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 PEDICAEL®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code HCPDT-IPV-PRP-T
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiphtheriae adsorbatum
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameDiphtheria Toxoid
    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.3.8INN - Proposed INNTetani adsorbatum
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTetanus Toxoid
    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.3.8INN - Proposed INNPertussis sine cellulis ex elementis praepartum adsorbatum (PT)
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePertussis Toxoid (PT)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertussis sine cellulis ex elementis praepartum adsorbatum (FHA)
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive nameFilamentous Haemagglutinin (FHA)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertussis sine cellulis ex elementis praepartum adsorbatum (FIM)
    D.3.9.2Current sponsor codeFIM
    D.3.9.3Other descriptive nameFimbrial Agglutinogens 2 and 3 (FIM)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertussis sine cellulis ex elementis praepartum adsorbatum (PRN)
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePertactin (PRN)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitidis inactivatum stirpe 1
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive nameInactivated Type 1 Poliovirus (Mahoney)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 to D-antigen units
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitidis inactivatum stirpe 2
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive nameInactivated Type 2 Poliovirus (MEF 1)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8 to D-antigen units
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitidis inactivatum stirpe 3
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive nameInactivated Type 3 Poliovirus (Saukett)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32 to D-antigen units
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaemophili stirpe b conjugatum
    D.3.9.2Current sponsor codePRP-T
    D.3.9.3Other descriptive nameHaemophilus influenzae type b polysaccharide conjugated to 20 micrograms of Tetanus Toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSmithKline Beecham plc
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiphtheriae adsorbatum
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameDiphtheria Toxoid
    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.3.8INN - Proposed INNTetani adsorbatum
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTetanus Toxoid
    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.3.8INN - Proposed INNPertussis sine cellulis ex elementis praepartum adsorbatum (PT)
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePertussis Toxoid (PT)
    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.3.8INN - Proposed INNPertussis sine cellulis ex elementis praeparatum adsorbatum (FHA)
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive nameFilamentous Haemagglutinin (FHA)
    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.3.8INN - Proposed INNPertussis since cellulis ex elementis praeparatum adsorbatum (PRN)
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePertactin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitidis inactivatum stirpe 1
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive nameInactivated Type I Poliovirus (Mahoney)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 D-antigen unit
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitidis inactivatum stirpe 2
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive nameInactivated Type 2 Poliovirus (MEF 1)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8 D-antigen units
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoliomyelitidis inactivatum stirpe 3
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive nameInactivated Type 3 Poliovirus (Saukett)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32 D-antigen unit
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaemophili stirpe b conjugatum
    D.3.9.2Current sponsor codeHib
    D.3.9.3Other descriptive nameHaemophilus influenzae b polysaccharide conjugated to 30 micrograms of Tetanus Toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    PEDIACEL® is a fully liquid combination vaccine indicated for infants from 2 months of age to protect against diseases caused by 5 common pathogens: Haemophilus influenzae type b, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2 and 3.
    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 assess the immunogenicity post-dose 3 of PEDIACEL® (Group A) and Infanrix™–IPV+Hib (Group B) when administered to infants at 3, 5 and 12 months of age.
    E.2.2Secondary objectives of the trial
    1. To describe the safety of PEDIACEL® and Infanrix™–IPV+Hib when administered to infants at 3, 5 and 12 months of age.
    2. To compare the post-dose 3 anti-PRP GMT responses of Pediacel® and Infanrix™–IPV+Hib.
    3. To describe the post-dose 2 and post-dose 3 antibody responses to all antigens included in the vaccines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Infants aged 80 to 120 days inclusive on the day of inclusion.
    2. Born at full term of pregnancy (>37 weeks).
    3. Informed consent form signed by the parent(s) or other legal representative according to local regulations.
    4. Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).
    E.4Principal exclusion criteria
    1. Rectal temperature ≥38.0°C
    2. Moderate or severe acute illness with or without fever
    3. Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
    4. Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination.
    5. Planned participation in another clinical trial during the present trial period.
    6. Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis.
    7. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
    8. Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
    9. History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances.
    10. Blood or blood-derived products (immunoglobulins) received in the past 4 weeks.
    11. Vaccination planned in the 6 weeks following any trial vaccination.
    12. Known HIV seropositivity.
    13. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
    14. History of seizures or progressive, evolving or unstable neurological condition.
    15. Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject (determined by the Investigator or sub-Investigator to be sufficient for exclusion).
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of subjects achieving 1-month (28-42 days) post dose 3 seroprotective titres to each of the following antigens:
    - Diphtheria (not less than 0.1 IU/mL)
    - Tetanus (not less than 0.1 IU/mL)
    - Hib (not less than 1.0 µg/mL)
    - Polio 1, 2, and 3 (not less than 8 reciprocal dilution)
    2. Proportion of subjects achieving 1 month (28-42 days) post-dose 3 seroresponse (defined as seropositivity) for each of the following pertussis antigens:·
    PT·
    FHA·
    PRN ·
    FIM
    Pertussis seroresponse is defined as detectable (above lower limit of quantitation [LLOQ]) antibodies at post-dose 3 in subjects with undetectable antibodies pre-vaccination, or at least maintenance of pre-vaccination antibody concentration in subjects who were initially seropositive.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    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.1.1.1In 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.1.1.5Children (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
    Infants and toddlers
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-08
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