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    Summary
    EudraCT Number:2018-002976-41
    Sponsor's Protocol Code Number:ZonMW522004008
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-24
    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 number2018-002976-41
    A.3Full title of the trial
    ‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?’
    te vroeg geboren kinderen en maternale kinkhoestvaccinatie; is vaccinatie in het tweede trimester een goede keuze?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?
    te vroeg geboren kinderen en maternale kinkhoestvaccinatie; is vaccinatie in het tweede trimester een goede keuze?
    A.3.2Name or abbreviated title of the trial where available
    PIMPI: Premature Infants and Maternal Pertussis Immunization
    PIMPI
    A.4.1Sponsor's protocol code numberZonMW522004008
    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 supportZonMW
    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 PIMPI-study
    B.5.3 Address:
    B.5.3.1Street AddressPObox 1
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720BA
    B.5.3.4CountryNetherlands
    B.5.6E-mailpimpi@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 holderGlaxoSmithKline BV
    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.3.1Product nameBoostrix
    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) No
    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
    women in their first trimester of pregnancy
    vrouwen in het eerste trimester van hun zwangerschap
    E.1.1.1Medical condition in easily understood language
    women in their first trimester of pregnancy
    vrouwen in het eerste trimester van hun zwangerschap
    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 non-inferiority of anti-Pertussis Toxin (PT) IgG in term infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w Gestational Age (GA) compared to a reference anti-PT IgG at 2m of age in a historical control group of term infants born of mothers who were vaccinated between 30-32w GA.
    Likewise, we aim to assess non-inferiority of anti-PT IgG in preterm infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w GA compared to the 20 IU/ml anti-PT IgG cut-off used in many immunogenicity studies.
    het evalueren van non-inferioriteit van anti-PT IgG in op tijd geboren kinderen op leeftijd van 2m, die geboren zijn uit moeders, die tussen 20-24w zwangerschapsduur gevaccineerd zijn tegen kinkhoest t.o.v. een historische controle groep van op tijd geboren kinderen van moeders, die gevaccineerd zijn tussen 30-32w zwangerschapsduur. Daarnaast evalueren we of de anti-PT IgG in te vroeg geboren kinderen op leeftijd van 2m en geboren uit moeders, die gevaccineerd zijn tegen kinkhoest tussen 20-24w zwangerschapsduur non-inferieur is t.o.v. een afkapwaarde van 20IU/ml
    E.2.2Secondary objectives of the trial
    -Compare pertussis specific IgG at 2m of age (i.e. before the first infant vaccination) between preterms and terms.
    -Compare the decay between birth and 2 month of age in pertussis specific maternal IgG between terms and preterms at 2m
    -Compare pertussis specific IgG at delivery between mothers who delivered preterm and term.
    -Compare immunogenicity in mothers who received 2nd trimester pertussis vaccination and a group that received 3rd trimester immunization.
    -Determine levels of pertussis specific IgG transferred from mother to neonate relative to the interval from immunization to delivery, depending on the variation in interval.
    -Assess tolerability of maternal Tdap vaccination, administered to pregnant women between 20-24wG A.
    -Assess possible adverse pregnancy outcomes of this maternal vaccination between 20-24w GA
    --Assess social cognitive determinants and underlying beliefs of maternal pertussis immunization between 20-24w GA and their correlation with behavior

    -vergelijken van pertussis specifiek IgG op leeftijd van 2m tussen te vroeg en op tijd geboren kinderen.
    -vergelijken van daling tussen geboorte en 2m van kinkhoest specifiek IgG in op tijd en te vroeg geboren kinderen.
    -vergelijken van pertussis specifiek IgG tijdens geboorte in moeders van op tijd en te vroeg geboren kinderen.
    -vergelijken van immunogeniciteit van 2de en 3de trimester maternale kinkhoestvaccinatie.
    - bepalen van hoeveelheid overgedragen pertussis specifiek IgG van moeder naar kind gerelateerd aan tijd tussen vaccinatie en bevalling.
    -bepalen van de tolerabiliteit van 2de trimester maternale kinkhoestvaccinatie.
    -bepalen van mogelijke negatieve zwangerschapsuitkomsten van 2de trimester maternale kinkhoestvaccinatie
    -bepalen van sociaal cognitieve determinanten en overtuigingen t.a.v. kinkhoestvaccinatie tussen 20-24w zwangerschapsduur en hun relatie met gedrag.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years or older
    2. Being pregnant
    3. Having an antenatal appointment with a midwife or obstetrician in the 1st trimester of pregnancy
    4. Signed informed consent
    5. Parents who are willing to adhere to the protocol and perform all planned visits and
    sample collections for themselves and their newborn child (only relevant for the immunogenicity part
    1. 18 jaar of ouder
    2. in eerste trimester van zwangerschap zijn en afspraak met met verloskundig zorgverlener
    3. getekend toestemmingsformulier
    4. bereidheid mee te werken aan bloedafnames
    E.4Principal exclusion criteria
    1. All women with one or more missing inclusion criteria
    2. History of having received a pertussis containing vaccination in the past 2 years.
    3. History of having had pertussis disease in the past 5 years.
    4. 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.
    5. Receipt of any high-dose (≥20 mg of prednisone daily or equivalent) daily corticosteroids within 2 weeks of study entry (inhaled or other local steroids are acceptable) with exception of corticosteroids to enhance maturation of fetal lungs in case of imminent early delivery.
    6. Receipt of other immune modulating medication, for instance biologicals.
    7. Receipt of blood products or immunoglobulins, within three months of study entry
    (Rhesus negative women who receive anti-rhesus (D)- immunoglobulin will not be
    excluded from the study).
    8. Presence of bleeding disorder.
    9. Having experienced a previous severe adverse reaction to any vaccine.
    10. Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza
    vaccine which may be given concomitantly).
    1. vrouwen met 1 of meer missende inclusiecriteria
    2. kinkhoestvaccinatie in afgelopen 2jr
    3. kinkhoest in afgelopen 5jr
    4. ernstig onderliggend lijden dat kan interfereren met de studie resultaten, zoals maar niet gelimiteerd tot kanker, auto-immuunziekte.
    5. toediening van hoge dosis corticosteroïden binnen 2wk voor deelname m.u.v. corticosteoriden i.v.m. longrijping kind bij dreigende vroeggeboorte.
    6.toedieing van andere immuun modulerende medicatie
    7. toediening van bloedprodukten of immunoglobulinen m.u.v. anti-D binnen 3m voor deelname
    8. stollingsstoornis
    9. ernstige bijwerking op eerdere vaccinatie
    10. toediening van vaccin binnen 2wk voor deelname m.u.v. influenza, dat gelijktijdig gegeven mag worden


    E.5 End points
    E.5.1Primary end point(s)
    Serum IgG antibody levels against vaccine antigen PT in preterm and term infants at 2 months of age, before start of infant vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    blood sampling at birth (mother and infant) and at 2m of age (infant)
    E.5.2Secondary end point(s)
    1. The IgG antibody concentration against pertussis toxin (PT), pertactin (Prn) filamentous hemagglutinin (FHA), tetanus and diphtheria in the mother at delivery.
    2. The IgG antibody concentration against PT, Prn, FHA, tetanus and diphtheria in the infant at birth (cord blood).
    3. The IgG antibody concentration against Prn, FHA, tetanus and diphtheria in the infant at 2m of age.
    4. The decay in IgG antibody concentration against PT, Prn, FHA, tetanus and diphtheria in infants from birth until 2 months of age.
    5. The ratio between maternal GMCs and infant GMCs at birth
    6. Frequency of local and systemic adverse events occurring within 7 days after vaccination during pregnancy.
    7. Frequency of systemic events, occurring in the week before vaccination.
    8. Prediction factors of women’s attitude towards maternal pertussis vaccination between 20-24w GA
    9. Frequencies of perinatal outcomes, i.e. delivery mode, apgar score, umbilical blood gas, neonatal hospitalization, reason for neonatal hospitalization, duration of neonatal hospitalization, hospitalization in first 2 months of life, reason for this hospitalization, duration of this hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    blood sampling at birth (mother and infant) and at 2m of age (infant)
    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 on anti-PT IgG at 2m of age in infants born of mothers who were vaccinated against pertussis between 20-24w GA
    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 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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 120
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 60
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 60
    F.1.1.4Infants and toddlers (28 days-23 months) No
    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: 120
    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 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.4.1In the member state120
    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 Decision2019-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-27
    P. End of Trial
    P.End of Trial StatusOngoing
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