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    Summary
    EudraCT Number:2010-019383-36
    Sponsor's Protocol Code Number:670901
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-21
    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
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-019383-36
    A.3Full title of the trial
    A Phase IIIB, Randomized, Open Label, Feasibility Study of a Single Priming Dose of
    Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NeisVac-C Single Primary Dose Study in Infants
    A.3.2Name or abbreviated title of the trial where available
    NeisVac-C Single Prime Study in Infants
    A.4.1Sponsor's protocol code number670901
    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 SponsorBaxter Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxter Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointGuido Wuerth, MD
    B.5.3 Address:
    B.5.3.1Street AddressWagramer Strasse 17-19
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1221
    B.5.3.4CountryAustria
    B.5.4Telephone number+43(0)1201003489
    B.5.5Fax number+43(0)120100717
    B.5.6E-mailguido_wuerth@baxter.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 Yes
    D.2.1.1.1Trade name NeisVac-C Baxter
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Polska Sp.z.o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMeningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed
    D.3.2Product code n.a.
    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.3.9.1CAS number 0
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP C CONJUGATE VACCINE
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Active immunization for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.
    E.1.1.1Medical condition in easily understood language
    Prevention of encephalitis and/or blood poisoning (sepsis) caused my meningococcal bacteria
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10028911
    E.1.2Term Neisseria meningitidis infection NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response
    E.2.2Secondary objectives of the trial
    To evaluate vaccine safety in infants as determined by local and systemic reactions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Approximately 948 infants (aged 2 months) who meet ALL of the following criteria are eligible for this study:
    • Subject is an infant aged 8 to 11 weeks at the time of first vaccination;
    • Subject is clinically healthy as determined by the investigator’s clinical judgment through collection of medical history and physical examination;
    • Subject was born at full term of pregnancy (equal to or above 37 weeks) with a birth weight equal to or above 2.0 kg;
    • The parent(s) or legally authorized representative of the subject provides written consent for participation;
    • The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol;
    • The parent(s) or legally authorized representative and the subject will be available for the duration of the study;
    • The parent(s) or legally authorized representative of the subject agrees to keep a subject diary
    E.4Principal exclusion criteria
    Subjects who meet ANY of the following criteria are not eligible for this study:
    • Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines;
    • Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study;
    • Subject has a rash or dermatologic condition which may interfere with injection site reaction rating;
    • Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder;
    • Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response (such treatment includes, but is not limited to: systemic or high dose inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs);
    • Subject has received any blood products or immunoglobulins within 60 days of study entry;
    • Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination;
    • Subject has previously been vaccinated against meningococcal C disease;
    • Subject has a known or suspected immune dysfunction;
    • Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.);
    • Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product;
    • Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study Investigator or with a study team member. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings) as well as employees of the Investigator or site conducting the study.
    E.5 End points
    E.5.1Primary end point(s)
    There are three co-primary end points related to immunogenicity:
    • Number of subjects with seroprotective antibody titers (rSBA titers ≥ 8) one month after completion of the primary vaccination in single dose groups compared to the two dose group and;
    • Number of subjects with seroprotective antibody titers (rSBA titers ≥ 8) prior to the administration of the booster dose and;
    • Number of subjects with seroprotective antibody titers (rSBA titers ≥ 128) one month after the administration of the booster dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after completion of the primary vaccination, prior to the administration of the booster dose, and one month after the administration of the booster dose.
    E.5.2Secondary end point(s)
    Immunogenicity
    rSBA titers one month after completion of the primary vaccination;
    rSBA titers prior to the administration of the booster dose;
    rSBA titers one month after the administration of the booster dose.

    Safety
    Frequency and severity of local and systemic reactions with onset within 3 days after each vaccination
    Frequency and severity of adverse events (AEs) observed during the entire follow-up period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity
    One month after completion of the primary vaccination, prior to the administration of the booster dose, and one month after the administration of the booster dose.

    Safety
    Evaluation of local and systemic reactions within 3 days after each vaccination and of adverse events (AEs) during the entire follow-up period.
    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 Yes
    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) Yes
    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 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
    Approved infant schedule serves as control.
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Yes
    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
    n.a.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 948
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 948
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    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
    The population of the study consists of infants 2 months of age up to 13 months of age. Informed consent form will be signed by their parents/legal guardians.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state900
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 948
    F.4.2.2In the whole clinical trial 948
    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)
    n.a.
    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 Decision2010-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-31
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