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    Summary
    EudraCT Number:2010-020840-36
    Sponsor's Protocol Code Number:V98_04
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-11
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2010-020840-36
    A.3Full title of the trial
    A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B strep. Vaccine in Healthy Pregnant Women.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune Response Induced by a Trivalent Group B strep. vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings.
    A.4.1Sponsor's protocol code numberV98_04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01446289
    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 SponsorNovartis Vaccines and Diagnostics
    B.1.3.4CountryItaly
    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 supportNovartis Vaccines and Diagnostics
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines
    B.5.2Functional name of contact pointPosting Director
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina, 1
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.6E-mailRegistryContactVaccinesUS@novartis.com
    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 No
    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 nameTrivalent Group B Streptococcus Glycoconjugate Vaccine
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis against Group B Streptococcus infection.
    E.1.1.1Medical condition in easily understood language
    Bacterial Infection
    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
    To evaluate placental transfer of anti-Group B strep. CPS antibodies against vaccine serotypes among infants born to vaccine and placebo injected mothers.
    E.2.2Secondary objectives of the trial
    Pregnant Woman:
    To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects 30 days post injection.

    To evaluate the kinetics of anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects at baseline, 30 days post vaccination, delivery and 3 months after delivery.

    Infant:
    To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in infants born to vaccinated subjects at birth and 3 months of age.

    To evaluate the response to routine anti-diphtheria vaccination among infants born to vaccine and placebo vaccinated subjects at 1 month after the third routine
    vaccination.

    Safety objective:
    Pregnant Woman:
    To evaluate safety and tolerability of a trivalent Group B strep. vaccine (5/5/5 micro gram of each glycoconjugate).

    Infants:
    To evaluate outcome of infants born to vaccine and placebo recipients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation
    2) Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
    3) Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
    4) Individuals who will be available for all scheduled visits (i.e. not planning to leave the area before the end of the study period).
    E.4Principal exclusion criteria
    1) Individuals who are unwilling and/or unable to give written informed consent to participate in the study.
    2) Individuals with a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
    3) Individuals with any known or suspected impairment/alteration of immune function, either congenital or resulting from:
    • receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 15 mg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy, Topical corticosteroids are allowed)
    • receipt of immunostimulants
    • receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within 12 weeks prior to enrollment and for the full length of the study
    Note: Anti-D Immunoglobulins given for Anti-D prophylaxis are allowed.
    4) Individuals characterized as “high risk” pregnancies at investigator discretion, such as those who have
     gestational diabetes
     pre-eclampsia/eclampsia,
     women at risk of pre-term labor (except positivity for vaginal Group B strep.)
     History of previous pregnancy complications including delivery of pre-term infant
     History of still-birth, late abortions and children with congenital anomalies
    5) Individuals who receive any other investigational agent or investigational intervention during the course of the study.
    6) Individuals with acute infection including oral temperature ≥ 38°C are temporarily excluded. They may be enrolled once the infection has resolved (as judged by investigator).
    7) HIV positive by history
    8) Individuals reporting any known or suspected serious acute, chronic or progressive disease (e.g., any history of neoplasm, malignancy, including lymphoproliferative disorder, diabetes, cardiac disease, malnutrition, renal failure, autoimmune disease, HBV or HCV, blood disorders).
    Note: Malignancies, highly likely to having been cured at the investigators discretion are allowed. (e.g. no relapse since 5 years post last malignancy specific treatment)
    9) Individuals with bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    10) Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study (e.g. who are not able to comprehend or to follow all required study procedures for the whole period of the study).
    11) Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
    12) Individuals with history or any illness that, in the opinion of the investigator, might pose additional risk to subjects due to participation in the study.
    13) Individuals who are part of study personnel or close family members conducting this study
    E.5 End points
    E.5.1Primary end point(s)
    Transfer rate (%) and concentration (μg/mL) of maternal anti-Group B strep. CPS antibody that is transferred to the newborn, calculated as the ratio between cord blood antibody level (μg/mL) and maternal antibody level (μg/mL) at time of delivery, per each serotype.

    E.5.1.1Timepoint(s) of evaluation of this end point
    at the time of delivery.
    E.5.2Secondary end point(s)
    Pregnant Women:
    1) GMC and GMR (i.e. GMC at different time points over baseline) of anti- Group B strep. CPS antibody at study day 1 (GMC only), study day 31, at delivery (GMR only), and at 3 months post-delivery.

    Infants:
    2) GMC of anti- Group B strep. CPS antibody in infants at 3 months of age.

    3) GMC of anti-diphtheria antibodies in sera of infants collected at 1 month after the last routine infant immunization.

    Safety Endpoints:
    4) Number of local and systemic reactions reported during 1 to 7 days after vaccination.

    5) All adverse events occuring throughout the study for pregnant women and for infants at 3months of age and 1month after routine vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) day 1, day 31, 3 months post delivery.

    2) at 3 months of age.

    3) 1 Month after last routine infant immunization

    4) 1 to 7 Days after vaccination.

    5) throughouth the study fro pregnant women and for infants at 3 months of age and 1t 1 month after routine vaccination
    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
    Immunogenecity
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Belgium
    Canada
    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 subject last visit 17 OCt 13
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months9
    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 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: 100
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    NA
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Canada
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