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    Summary
    EudraCT Number:2011-001936-45
    Sponsor's Protocol Code Number:matab4
    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:2011-04-28
    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 number2011-001936-45
    A.3Full title of the trial
    Pertussis vaccination in pregnancy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination against whooping cough in pregnancy
    A.3.2Name or abbreviated title of the trial where available
    matab4
    A.4.1Sponsor's protocol code numbermatab4
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 holderGSK
    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 nameBoostrix
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameDIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS
    D.3.9.4EV Substance CodeSUB13628MIG
    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
    The number of reported pertussis cases is rising, also in very young infants. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants
    E.1.1.1Medical condition in easily understood language
    Whooping cough occurs in infants too young to be immunized. The administration of a booster dose against whooping cough during pregnancy will augment the transferred maternal protection to the infant.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Can vaccination of pregnant women with a combined vaccine Tetanus, diphtheria and acellular pertussis (Tdap), reduce the gap of susceptibility to pertussis disease in newborns by augmenting maternal antibody concentrations?
    E.2.2Secondary objectives of the trial
    Is there a difference in humoral immune responses to pertussis containing vacicnes, between children from women who received a booster vaccine during pregnancy and age matched control infants?

    Safety data on vaccination during pregnancy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    - Women aged 18-35 years
    - Willing to be immunized during pregnancy
    OR
    Received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner.
    - Age matched controls will be identified in the same time period in the recruiting hospital.
    - Intend to be available for follow-up visits and phone call access through 16 months following delivery
    - Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal Belgian schedule) with pediatrician, the general practitioner or at the Centre for the Evaluation of Vaccination.
    - In the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician and some of the following criteria:
    1. Second trimester ultrasound with no significant abnormalities
    2. No chromosomal abnormalities identified by diagnostic testing (CVS or amniocentesis)
    3. Pregnancy estimated to be at low risk (< 1 / 300) for Down's syndrome (trisomy 21), trisomy 13 and trisomy 18 tested at 11-13 weeks of gestation. Appropriate screening test includes any one of the following:
    a. second trimester screening based on
    i. nuchal translucency measurement,
    ii. pregnancy-associated serum protein A (PAPP-A) and free beta- human chorionic gonadotropin (β-HCG)
    taking into account maternal age and pregnancy duration
    b. first trimester ultrasound screening and second trimester maternal serum screening test that looks for four specific substances: AFP, total HCG, Estriol (and Inhibin-A), with risk estimated using an integrated, sequential, or contingency approach, and taking into account maternal age
    c. second trimester maternal serum screening test that looks for four specific substances: AFP, total hCG, Estriol (and Inhibin-A)
    E.4Principal exclusion criteria
    A. Pregnant women
    - Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
    - Significant mental illness (e.g. schizophrenia, psychosis, major depression)
    - History of a febrile illness (greater than or equal to 38° Celsius) within the past 72 hours before injection
    - Previous severe reaction to any vaccine
    - Receipt of tetanus-diphtheria toxoid immunization within the past 2 years
    - Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization in the last 10 years
    - Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection
    - Receipt of or plans to receive influenza vaccine within the 2 4weeks prior to or following injection. One month interval should be respected in order to evaluate eventual Adverse events following one of both vaccines (fever, local symptoms).
    - Deemed high risk for serious obstetrical complication
    - Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk

    B. Children with following criteria
    - Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
    - No signed informed consent by both parents
    - Severe reactions to any vaccine
    - Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
    E.5 End points
    E.5.1Primary end point(s)
    1.What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN):
    a.in women during pregnancy and at delivery after vaccination with TdaP
    b.in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16)
    2.What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants
    E.5.1.1Timepoint(s) of evaluation of this end point
    Women: vaccination between 18 and 32 weeks of pregnancy, blood sampling one month after vaccination, blood sampling at delivery.
    Children are included after delivery and 2 different groups can be recognized according to whether the mother received a booster vaccine. Infants are offered pertussis immunization according to the official recommendations in Flanders, at week 8, 12, 16 (hexavalent vaccine), at month 15 and year 6 (tetravalent vaccine). Blood sampling will be performed (2.5 cc) from the cord and in the children at week 8 (pre-vaccination), week 20 (after vaccination), month 15 (pre-boost) and month 16 (post-booster vaccination).The aim is to take 2,5 cc of whole blood per sampling time point in children.
    E.5.2Secondary end point(s)
    Secondary outcome measures:
    a. Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
    b. Infant growth measurements (head circumference, length and weight) at all time points
    c. Developmental screening of the infants (at 15 months of age)
    d. Compare the immune mechanisms to age-matched infants, whose mothers did not receive a pertussis booster vaccination during the last 10 years before pregnancy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Women: vaccination between 18 and 32 weeks of pregnancy, blood sampling one month after vaccination, blood sampling at delivery.
    Children are included after delivery and 2 different groups can be recognized according to whether the mother received a booster vaccine. Infants are offered pertussis immunization according to the official recommendations in Flanders, at week 8, 12, 16 (hexavalent vaccine), at month 15 and year 6 (tetravalent vaccine). Blood sampling will be performed (2.5 cc) from the cord and in the children at week 8 (pre-vaccination), week 20 (after vaccination), month 15 (pre-boost) and month 16 (post-booster vaccination).The aim is to take 2,5 cc of whole blood per sampling time point in children.
    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 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 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
    no vaccination
    E.8.2.4Number of treatment arms in the trial1
    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
    End of the trial is foreseen after 4 years, including a few months for analysis and interpretation of the data
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 100
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 100
    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: 100
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    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: 100
    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 Yes
    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
    Children younger than 18 years, both parents will be asked to sign informed consent for the child, as necessary accoridng to the belgian law.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    No difference is expected
    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 Decision2011-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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