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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003090-98
    Sponsor's Protocol Code Number:IIV-266
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-09
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003090-98
    A.3Full title of the trial
    Maternal pertussis (Tdap) vaccination and its effects on the immune response of the newborn up to 12 months of age.
    Maternale Kinkhoest vaccinatie en de effecten hiervan op de immuunrespons van baby's t/m 12 maanden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of Pertussis vaccination of pregnant woman on the production of antibody's in the blood of newborns up to 12 months of age
    De effecten van vaccinatie van de moeder tegen kinkhoest tijdens de zwangerschap op de bescherming van de baby t/m 12 maanden
    A.3.2Name or abbreviated title of the trial where available
    MIKI
    Maternale Immunisatie Kinkhoest= MIKI
    A.4.1Sponsor's protocol code numberIIV-266
    A.5.4Other Identifiers
    Name:ABRNumber:NL-45652.000.13
    Name:NTRNumber:16010
    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 SponsorRIVM
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry of Health, Welfare and Sport (VWS).
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRIVM
    B.5.2Functional name of contact pointInformation MIKI study
    B.5.3 Address:
    B.5.3.1Street AddressAntonie van Leeuwenhoeklaan 9
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 MA
    B.5.3.4CountryNetherlands
    B.5.6E-mailMIKI@rivm.nl
    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 Boostrix
    D.2.1.1.2Name of the Marketing Authorisation holderRVG 35121
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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: 2
    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 Synflorix
    D.2.1.1.2Name of the Marketing Authorisation holderEU/1/09/508/001
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 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 Infanrix hexa
    D.2.1.1.2Name of the Marketing Authorisation holderEU/1/00/152/001
    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.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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
    Healthy pregnant woman < 20 months pregnant
    Gezonde zwangere vrouwen < 20 maanden zwanger
    E.1.1.1Medical condition in easily understood language
    Healthy pregnant woman < 20 months pregnant
    Gezonde zwangere vrouwen < 20 maanden zwanger
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of mothers who have been vaccinated postpartum.
    Het verschil bepalen van het de IgG antistof levels tegen Pertussis toxine tussen baby's van 3 maanden waarvan de moeders wel respectievelijk niet gevaccineerd zijn tijdens de zwangerschap
    E.2.2Secondary objectives of the trial
    Determine effect of maternal antibodies on infant's immune response to active immunization with pertussis (PT) vaccine and on routine DTaP-IPV-Hib-Hep and PCV10 vaccination
    Compare serum IgA levels against PT antigens of infants of both groups
    Determine rate of maternal antibody decline in infants between birth and at 2 and 3 months of age before first PT vaccination
    Determine levels of PT IgG antibodies transferred from mother to neonate
    Assess cellular immune response (Pl B cells and Mem B cells) before and 7-9 days after the booster at 11-months of age
    Safety evaluation after Boostrix vaccination during pregnancy
    Assess PT IgG antibody levels in mothers of both groups, pre-vaccination, at delivery and 6, and 12 months post-delivery;
    Compare infants’ pain response and maternal attitude to infant blood collection by heel stick and venipuncture.
    Compare IgA levels against PT antigens in breast milk of mothers of both groups at 7-10 days, 3 months and 6 months after delivery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pregnant women 18-40 years of age
    • Women with a low risk of pregnancy complications as assessed by a midwife/obstetrician/gynaecologist with a normal 20 weeks ultrasound of the fetus
    • Women who are willing to adhere to the protocol and perform all planned visits and sample collections for themselves and their newborn child
    • Parents have to be willing to have their infant vaccinated with the hexavalent (DaKTP-Hib-Hep) vaccine at 3, 5 and 11 months of age according to the described procedures
    • Presence of a signed informed consent
    E.4Principal exclusion criteria
    Pregnant Woman:
    History of having received a pertussis vaccination in the past 5 years
    - History of having received a TD containing vaccine in the past 2 years
    - Known or suspected serious underlying condition that can interfere with the results of the study such as but not limited to cancer, autoimmune disease, immunodeficiency, seizure disorder or significant psychiatric illness
    - Receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry
    - Receipt of other immune modulating medication, for instance biologicals
    - Receipt of blood products or immunoglobulin, within three months of study entry (Rhesus negative women who receive antirhesus (D)- immunoglobuline will not be excluded from the trial)
    - Presence of bleeding disorder
    - Having experienced a previous severe adverse reaction to any vaccine
    - Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza vaccine which may be given concomitantly)
    - History of febrile illness (>38.0°C orally) within the past 72 hours (immunization may be deferred)

    Exclusion criteria for newborns of participating mothers:
    • Serious underlying medical condition that can interfere with the results of the study
    • Premature infants born before 37 weeks gestational age

    E.5 End points
    E.5.1Primary end point(s)
    Difference in infant serum IgG antibody levels against pertussis vaccine antigen Ptx at 3 months of age, before start of infant vaccination, between both groups
    E.5.1.1Timepoint(s) of evaluation of this end point
    Infants 2 and 3 months of age, before start of primary vaccination series
    E.5.2Secondary end point(s)
    1 Difference between both groups in serum IgG antibody levels against pertussis vaccine antigens Ptx, FHA and Prn of the newborns
    2 Difference between both groups in serum IgA antibody levels against pertussis vaccine antigens Ptx, FHA and Prn of the new-borns
    3 Difference between both groups in serum IgG antibody levels against tetanus and diphtheria to assess influence of maternal antibodies on the response to D and T vaccination of the new-borns.
    4 Difference between both groups in serum IgG antibody levels against other concomitantly administered vaccine components Hib, HepB and pneumococcal serotypes(PCV10) of the new-borns
    5 Difference between both groups in serum IgG antibody levels against pertussis vaccine antigens Ptx, FHA and Prn of the mothers,
    6 Frequency of local and systemic reactions after Tdap vaccination during pregnancy
    7 Frequency of pertussis specific memory B-cells and plasma cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: infants at birth and at 2,3,6,11 and 12 months of age
    2: infants at birth and at 2,3,6,11 and 12 months of age
    3: infants at birth and at 2,3,6,11 and 12 months of age
    4: infants at birth and at 2,3,6,11 and 12 months of age
    5: mothers pre vaccination (group 1), at birth, and at 6 and 12 months after birth
    6: mothers up to 5 days after vaccination (Group 1)
    7: infants immediately before and 7-9 days after the booster dose at 11 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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
    Effect of maternal Pertussis vaccination on the Immuunrespons of Infants up to 12 months of age
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 112
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 112
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 112
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 112
    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 No
    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 Yes
    F.3.3.4Nursing women Yes
    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.4.1In the member state224
    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 Decision2013-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-22
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