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    Summary
    EudraCT Number:2021-005194-77
    Sponsor's Protocol Code Number:Matimmunestudyversion2
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-005194-77
    A.3Full title of the trial
    The optimal timing of vaccination in pregnancy: a multi-dimensional mechanistic approach to measure immune responses in pregnant women
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The optimal timing of vaccination in pregnancy
    A.3.2Name or abbreviated title of the trial where available
    MATIMMUNE
    A.4.1Sponsor's protocol code numberMatimmunestudyversion2
    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 SponsorUniversity of Antwerp
    B.1.3.4CountryBelgium
    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 supportFonds Wetenschappelijk Onderzoek
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Antwerp
    B.5.2Functional name of contact pointKirsten Maertens
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitsplein 1
    B.5.3.2Town/ cityWilrijk
    B.5.3.3Post code2610
    B.5.3.4CountryBelgium
    B.5.6E-mailkirsten.maertens@uantwerpen.be
    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 Triaxis
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameTriaxis
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    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 INNpurified, inactivated diphtheria toxin (DT)
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpurified, inactivated tetanus toxoid (TT)
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpurified, inactivated pertussis toxin (PT)
    D.3.9.1CAS number 93384-51-1
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    D.3.9.4EV Substance CodeSUB14817MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpurified, inactivated Filamentous Haemagglutinin (FHA)
    D.3.9.3Other descriptive nameFILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB38509
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpurified, inactivated pertussis pertactin (Prn)
    D.3.9.3Other descriptive namePERTUSSIS PERTACTIN
    D.3.9.4EV Substance CodeSUB20527
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFIM2 and FIM3
    D.3.9.3Other descriptive namePERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3
    D.3.9.4EV Substance CodeSUB25272
    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
    humoral and cellular immune responses to pertussis vaccine during pregnancy
    E.1.1.1Medical condition in easily understood language
    response to vaccination against the pertussis
    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
    The main objective of this study is to investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during and after pregnancy.
    E.2.2Secondary objectives of the trial
    In this study we will also investigate: the impact of timing of vaccination during pregnancy on cellular immune responses in pregnant women at several timepoints during and after pregnancy; the impact of timing on vaccination during pregnancy on antibody characteristics that are optimally transferred across the placenta and on transplacental transport efficiency; the impact of maternal Tdap vaccination and timing of maternal Tdap vaccination on breast milk antibody composition at several timepoints postpartum; the impact of vaccination during pregnancy on the mucosal uptake of breast milk IgA antibodies by the infant respiratory and gastrointestinal tract.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female population older than 18 years.
    • Ability to provide informed consent.
    • Willing to be vaccinated with a Tdap vaccine during pregnancy.
    • Intend to be available for follow-up visits and phone call access until 6 months postvaccination.
    • Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.
    E.4Principal exclusion criteria
    • Vaccinated with an aP containing vaccine during the last 5 years
    • Significant mental illness (e.g. schizophrenia, psychosis, major depression)
    • Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human
    immunodeficiency virus (HIV) infection…).
    • Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg
    prednisone or equivalent.
    • Anything in the opinion of the investigator that would prevent volunteers from completing the study or
    put the volunteer at risk.
    • Previous severe reaction to any vaccine
    • High risk for serious obstetrical complications.
    E.5 End points
    E.5.1Primary end point(s)
    To investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during pregnancy, at delivery and at several timepoints after delivery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • During pregnancy: before Tdap vaccination; one month after Tdap vaccination; at an interval of every 4 weeks until delivery occurs
    • At delivery
    • After delivery: 2/4/8/12 weeks and 6 months postpartum
    E.5.2Secondary end point(s)
    • To investigate the impact of timing of vaccination during pregnancy on cellular immune responses in pregnant women at several timepoints during pregnancy (before Tdap vaccination and one month after Tdap vaccination), at delivery and after delivery (6 months postpartum).
    • To investigate the impact of timing of vaccination during pregnancy on antibody characteristics that are optimally transferred across the placenta and on transplacental transport efficiency.
    • To investigate the impact of maternal Tdap vaccination and timing of maternal Tdap vaccination on breast milk antibody composition at several timepoints postpartum (<72 hours postpartum, 2/4/8/12 weeks postpartum).
    • To investigate the impact of vaccination during pregnancy on the mucosal uptake of breast milk IgA antibodies by the infant respiratory and gastrointestinal tract
    E.5.2.1Timepoint(s) of evaluation of this end point
    • During pregnancy: before Tdap vaccination; one month after Tdap vaccination; at an interval of every 4 weeks until delivery occurs
    • At delivery
    • After delivery: 2/4/8/12 weeks and 6 months postpartum
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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
    vaccination during pregnancy at 3 different timepoints are compared to each other
    E.8.2.4Number of treatment arms in the trial3
    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 years1
    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 No
    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) 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: 90
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 state90
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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